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China’s first BCMA CAR-T therapy successfully treats an overseas patient with advanced relapsed multiple myeloma
China’s first BCMA CAR-T therapy successfully treats an overseas patient with advanced relapsed myeloma.
🎉🎉To assess whether the condition is suitable for CAR-T or clinic therapy, you can submit Advanced Medicine in China for preliminary evaluation!
WhatsApp:+8613717959070
Https://wa.me/+8613717959070
Email: doctor.huang@globecancer.com
#MultipleMyeloma #CAR-T #CancerTreatment #MedicalBreakthrough #Oncology #HealthcareInnovation #BCMACART
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**China’s CAR-T Therapy Approved for New Indication: Bringing New Hope to Relapsed Mantle Cell Lymphoma Patients**
**China’s CAR-T Therapy Approved for New Indication: Bringing New Hope to Relapsed Mantle Cell Lymphoma Patients**
![MCL](https://www.medtourcn.com/wp-content/uploads/2024/08/微信截图_20240830161806.jpg)
MCL
The approval of Relmacabtagene Autoleucel brings renewed hope for the treatment of relapsed or refractory mantle cell lymphoma (R/R MCL). MCL is a rare and aggressive subtype of non-Hodgkin lymphoma (NHL). Despite advancements in treatment options over recent years, patients with R/R MCL continue to face high relapse rates and poor prognoses. Therefore, there is an urgent need for more effective and innovative therapies to improve treatment outcomes and survival expectations for these patients.
Relmacabtagene, a CD19-targeted autologous CAR-T cell therapy, works by precisely targeting and attacking cancerous B cells. It has shown remarkable efficacy in clinical studies. On August 27, 2024, the National Medical Products Administration (NMPA) officially approved the new indication for Relmacabtagene, allowing its use in adult patients with relapsed or refractory mantle cell lymphoma who have undergone at least two prior systemic therapies, including Bruton tyrosine kinase inhibitors (BTKi). This approval marks another significant milestone following Relmacabtagene’s previous approvals for R/R large B-cell lymphoma (LBCL) and follicular lymphoma (FL).
The treatment of R/R MCL has always been challenging. Traditional therapies often yield limited long-term results, particularly for patients who have failed BTKi treatment, leaving them with fewer options. The emergence of Relmacabtagene offers a new treatment avenue for these patients. Clinical studies demonstrate that this CAR-T cell therapy can significantly extend progression-free survival (PFS) and overall survival (OS), with a favorable safety profile.
The approval of this new indication not only expands the use of Relmacabtagene in treating R/R MCL but also paves the way for future advancements in MCL treatment. The application of CAR-T cell therapy, especially in high-risk patients, has shown potential in overcoming aggressive lymphomas. For patients with complex genetic characteristics and challenging treatment profiles, Relmacabtagene is undoubtedly a powerful therapeutic option.
Looking ahead, Relmacabtagene is expected to benefit more R/R MCL patients in clinical practice, pushing the boundaries of treatment in this field. As research deepens and new therapies continue to emerge, Relmacabtagene is poised to play an increasingly important role in improving patient outcomes and extending survival, offering new hope to R/R MCL patients worldwide.
To assess whether the condition is suitable for CAR-T or clinic therapy, you can submit Advanced Medicine in Chinafor preliminary evaluation!
WhatsApp: +86137 1795 9070
(Http://wa.me/+8613717959070)
Email: doctor.huang@globecancer.com
#BloodCancerTreatment #CAR_TCellTherapy #CancerBreakthrough #Immunotherapy #BCMACART #MedicalAdvancements #CancerSurvivorship #ChinaMedicalInnovation #MCL #RRMCL #HopeForCancerPatients #Relmacabtagene #MCLTreatment #CancerBreakthrough #ChinaApproval #CAR_TCellTherapy #LymphomaTreatment #CancerInnovation #HematologyAdvances
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China’s Fully Human BCMA CAR-T Therapy: Bringing New Hope for High-Risk Relapsed/Refractory Multiple Myeloma
China’s Fully Human BCMA CAR-T Therapy: Bringing New Hope for High-Risk Relapsed/Refractory Multiple Myeloma
![Mutiple Myeloma](https://www.medtourcn.com/wp-content/uploads/2024/08/微信截图_20240829173316.jpg)
Mutiple Myeloma
Multiple Myeloma (MM) is a complex and aggressive cancer originating from plasma cells, posing significant treatment challenges due to its resistance to therapy. For patients with high-risk MM, especially those who experience relapse after multiple lines of treatment, finding an effective therapy is critical. Recently, Chinese medical team successfully treated a case of high-risk relapsed/refractory MM (RRMM) using fully human BCMA CAR-T cell therapy, offering new hope for such difficult cases.
**Case Overview**
The patient, a 56-year-old woman, presented with anemia during a routine check-up and was later diagnosed with MM. Despite undergoing several treatment regimens, including VRd (bortezomib, lenalidomide, dexamethasone) and Dara-DECP followed by autologous stem cell transplantation (ASCT), the disease continued to progress, with extramedullary disease (EMD) manifestations complicating the case.
**Challenges and Treatment Journey**
After initial treatments failed to achieve long-term remission, the patient’s condition worsened, with new lesions detected in the pancreas and multiple subcutaneous nodules indicating possible metastasis. Given the aggressive nature of the disease and the presence of EMD, which is associated with a poor prognosis, the medical team opted for a BCMA-targeted CAR-T cell therapy using Iquarense (Ikaros CAR-T), the first CAR-T product approved for MM treatment in China.
**CAR-T Therapy and Results**
Following pre-conditioning with a fludarabine-cyclophosphamide (FC) regimen, the patient received the BCMA CAR-T therapy. The treatment was well-tolerated, with only mild cytokine release syndrome (CRS) observed. Remarkably, within three months post-treatment, PET-CT scans showed no signs of active disease, and the patient achieved a complete response (CR), which has been sustained for eight months.
**Significance and Future Implications**
This case highlights the potential of BCMA CAR-T therapy as a powerful option for patients with high-risk, relapsed/refractory MM, particularly those with EMD. The successful outcome not only provides new hope for patients facing similar challenges but also contributes valuable insights for future treatment strategies. Iquarense, with its low immunogenicity and prolonged persistence in the body, represents a promising advance in the fight against this formidable disease.
For patients with high-risk MM, it is crucial to consider genetic factors, treatment response, and overall disease dynamics when selecting a therapeutic approach. As this case demonstrates, BCMA CAR-T therapy offers a viable path forward, particularly for those with limited options due to disease progression or EMD.
To assess whether the condition is suitable for CAR-T or clinic therapy, you can submit Advanced Medicine in China for preliminary evaluation!
WhatsApp: +8613717959070
(Http://wa.me/+8613717959070)
Email: doctor.huang@globecancer.com
#BloodCancerTreatment #CAR_TCellTherapy #CancerBreakthrough #Immunotherapy #BCMACART #MedicalAdvancements #CancerSurvivorship #ChinaMedicalInnovation #HopeForCancerPatients
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Multiple Myeloma Solution ** Breakthroughs and Hope in Blood Cancer Treatment**
Multiple Myeloma Solution
** Breakthroughs and Hope in Blood Cancer Treatment**
![Mutiple Myeloma](https://www.medtourcn.com/wp-content/uploads/2024/08/cvbnchfgyjuf6rr5tyrydxfrfes1.png)
Mutiple Myeloma
Multiple myeloma is a malignant blood cancer caused by the abnormal proliferation of plasma cells in the bone marrow, often affecting the bones, kidneys, and various organs and systems. With the advancement of modern medical technology, the understanding and treatment of multiple myeloma have greatly improved, bringing unprecedented hope to patients.
### Causes and Risk Factors of Multiple Myeloma
The causes of multiple myeloma are complex, typically involving multiple factors such as genetic mutations, immune system abnormalities, exposure to harmful chemicals, viral infections, and genetic predisposition. Additionally, lifestyle and environmental factors like smoking, obesity, and certain occupational exposures are also believed to increase the risk of developing the disease. With an aging population, the incidence of multiple myeloma is on the rise.
### Evolution of Treatment: Traditional and Innovative Approaches
Although multiple myeloma was once considered a difficult-to-treat disease, recent advancements in treatment methods have made significant progress. Traditional treatments include chemotherapy, radiation therapy, and bone marrow transplantation, which have extended patients’ survival to some extent but come with limited efficacy and significant side effects.
However, with advances in medical technology, new treatment options have emerged. Monoclonal antibodies have played a key role in treating multiple myeloma, targeting cancer cells precisely while reducing harm to healthy cells. Antibody-drug conjugates take this a step further by delivering chemotherapy drugs directly to cancer cells, enhancing efficacy while minimizing side effects.
Small molecule targeted drugs represent another breakthrough. These drugs inhibit specific genes or proteins in cancer cells, preventing their growth and spread. For example, BCL-2 inhibitors and protein kinase inhibitors have shown promising results in clinical trials, offering more treatment options.
### Immunotherapy: Leading the Future of Hope
Immunotherapy is becoming increasingly important in the treatment of blood cancers, especially in the field of multiple myeloma. By activating the patient’s own immune system to attack cancer cells, immunotherapy holds great promise. Among the most forward-looking therapies is CAR-T cell therapy. This treatment involves genetically modifying a patient’s T cells to recognize and kill cancer cells, and it has achieved remarkable results in multiple myeloma patients.
In recent years, China has made significant progress in the research and application of immunotherapy. Particularly in the field of blood cancers, China has developed a comprehensive treatment system with established protocols and consensus. The BCMA-targeted CAR-T cell therapy has shown deep and lasting efficacy in treating multiple myeloma, greatly improving patients’ disease-free survival rates. For instance, China’s fully human BCMA-targeted CAR-T product, Equecabtagene Autoleucel, has demonstrated the best data among CAR-T products for multiple myeloma, with a complete remission rate of 82.4%.
### Looking Ahead
With the continuous emergence of new drugs and therapies, the treatment of multiple myeloma is moving towards individualized and precision medicine. Patients not only experience extended lifespans but also regain their quality of life, returning to normalcy in their everyday lives and work. As medical advancements continue, there is reason to believe that multiple myeloma will no longer be an incurable disease, and every patient will be able to embrace a brighter future.
To assess whether the condition is suitable for CAR-T or clinic therapy, you can submit Advanced Medicine in China for preliminary evaluation!
WhatsApp: +8613717959070 (Http://wa.me/+8613717959070)
Email: doctor.huang@globecancer.com
#BloodCancerTreatment #CAR_TCellTherapy #CancerBreakthrough #Immunotherapy #BCMACART #MedicalAdvancements #CancerSurvivorship #ChinaMedicalInnovation #HopeForCancerPatients
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Иностранные пациенты ищут лечение: Лучшая терапия CAR-T в Китае! Первый российский пациент с множественной миеломой успешно очистил опухоль и достиг CR!
**Иностранные пациенты ищут лечение: Лучшая терапия CAR-T в Китае! Первый российский пациент с множественной миеломой успешно очистил опухоль и достиг CR!**
![可能是包含下列内容的图片:6 位用户、医院和文字](https://scontent-hkg1-2.xx.fbcdn.net/v/t39.30808-6/457056143_1047001964094660_6991546972008543734_n.jpg?stp=dst-jpg_p843x403&_nc_cat=107&ccb=1-7&_nc_sid=127cfc&_nc_ohc=bNg2cqooEcoQ7kNvgEjmHP-&_nc_ht=scontent-hkg1-2.xx&oh=00_AYDot2KO4j71OXNfoiezYMfvPdRXtZfQr2BHqULKdobqmA&oe=66D34F6A)
В течение пяти лет после постановки диагноза высокорисковой множественной миеломы, господин Ф. испытывал невыносимые страдания. Несмотря на различные схемы химиотерапии и два пересадок, ему не удавалось полностью избавиться от кошмара непредсказуемых рецидивов и прогрессирования опухоли. К счастью, к концу 2023 года его состояние временно стабилизировалось. В сопровождении ведущих гематологов из России, господин Ф. отправился в Китай для прохождения терапии CAR-T, достигнув оптимальных результатов с полным исчезновением опухоли и CR (полная ремиссия).
Достигнуто CR! В феврале 2024 года господин Ф. и его семья успешно вернулись в Россию, чтобы заново начать счастливую жизнь.
(Примечание: Для защиты конфиденциальности пациента в тексте использованы вымышленные имена, а также немного изменены медицинские данные и процесс лечения.)
![](https://www.medtourcn.com/wp-content/uploads/2024/08/zxcvxzcfvxbfxbnx1.png)
**Обычная боль в спине оказалась высокорисковой множественной миеломой**
Господин Ф., 63 года, занимает должность заместителя директора технического колледжа в Санкт-Петербурге, Россия. У него успешная карьера и счастливая семья: жена, один сын и две дочери. За несколько месяцев до Рождества 2017 года господин Ф. испытывал усиливающуюся боль в спине, с сильной болью в поясничной области. В сопровождении семьи он отправился в больницу для тщательного обследования. Окончательный диагноз оказался множественной миеломой, с остеолитическими поражениями в более чем трёх участках. Врач сообщил господину Ф., что на основе всесторонней оценки различных результатов анализов его миелома классифицируется как высокорисковая (IgG-тип, стадия DS-IIIА, стадия ISS-II), что делает её трудной для лечения, склонной к рецидиву и с плохим прогнозом. Это ужасное известие пришло настолько внезапно, что вся семья погрузилась в шок и панику. В интервью господин Ф. сказал: “В китайской культуре Конфуций говорил: ‘Когда Небеса собираются возложить на человека великую ответственность, они всегда сначала расстраивают его дух’, рассматривая это как жизненное испытание. В западной культуре это считается наказанием Бога, испытанием, которое нужно пережить, и исход полностью зависит от того, как человек справляется с этими трудностями. Я должен выбрать борьбу!”
**Рецидив и прогрессирование: неизбежный кошмар для пациентов с множественной миеломой**
После двух дней шока и паники господин Ф. решил собраться с силами и найти лучшее лечение для борьбы с опухолью. Господин Ф. и его семья консультировались со многими врачами и клиниками в Испании, Мюнхене и Хайдельберге. Узнав, что терапия CAR-T обладает замечательными целебными свойствами при злокачественных заболеваниях кроветворной системы, они почувствовали луч надежды, который вскоре угас. В то время терапия CAR-T была доступна в очень немногих странах, преимущественно в развитых, и астрономическая стоимость почти в миллион долларов делала её недоступной даже для зажиточного господина Ф. Чтобы как можно быстрее контролировать заболевание, в начале 2018 года господин Ф. прошел традиционное лечение по схеме CVD в России, а затем первую аутологичную трансплантацию костного мозга, достигнув частичной ремиссии (PR). К сожалению, всего через десять месяцев его множественная миелома рецидивировала. После перехода на схему второй линии химиотерапии, он прошел вторую аутологичную трансплантацию костного мозга. Несмотря на самое агрессивное лечение и пережитые опасные для жизни побочные эффекты, опухолевые очаги остались в его теле, как бомба замедленного действия, которая могла взорваться в любой момент. Хотя поддерживающая терапия временно стабилизировала заболевание, господин Ф. и его семья оставались настороже. Они знали, что высокорисковая миелома, скорее всего, вновь рецидивирует и прогрессирует в кратчайшие сроки. Если заболевание снова ухудшится, они окажутся в отчаянной ситуации без доступных методов лечения.
![](https://www.medtourcn.com/wp-content/uploads/2024/08/bvvbnmhyur531.png)
**Глобальное сравнение показывает, что лучшая CAR-T терапия находится в Китае!**
Чтобы полностью избавиться от рака и избежать кошмара постоянных рецидивов и ухудшений, через пять лет господин Ф. и его семья снова начали искать возможность излечения с помощью CAR-T терапии по всему миру. Они провели обширное исследование уже представленных на рынке CAR-T терапий и проконсультировались с множеством больниц и экспертов в Европе, включая Индию и Израиль. К его удивлению, за эти пять лет в этих странах не произошло значительных улучшений. Почти каждый эксперт упомянул, что китайские больницы достигли огромных успехов в области CAR-T, превзойдя даже Европу и США. Особенно в случае множественной миеломы, 30 июня 2023 года Китай представил первую в мире полностью человеческую BCMA CAR-T терапию – Икиоленс. Господин Ф. и его лечащий врач немедленно связались с Международной больницей Цзяхуэй в Шанхае для проведения первоначальной удалённой консультации. Больница Цзяхуэй, являясь онкологическим центром международного уровня с профессиональной мультидисциплинарной MDT командой, провела предварительную оценку. Они пришли к выводу, что план лечения Икиоленс (BCMA CAR-T) будет наиболее эффективным, разработали комплексный план и ответили на все вопросы и опасения господина Ф. и российских экспертов, в конечном итоге достигнув согласия по плану лечения.
![](https://www.medtourcn.com/wp-content/uploads/2024/08/微信截图_20240827135613.jpg)
Профессор Ли Хуа, директор онкологического центра Международной больницы Цзяхуэй, и его команда российских экспертов-гематологов обсудили план лечения господина Ф. Несмотря на то, что господин Ф. был несколько осведомлен о достижениях китайской медицины, он не мог представить, что здравоохранение Китая превзошло уровень развитых западных стран. Поэтому в ноябре 2023 года лечащий врач господина Ф., известный российский гематолог, сопровождал его в Китай для оценки на месте возможности применения китайской CAR-T терапии. Их первой остановкой по прибытии в Китай была встреча с международной мультидисциплинарной командой больницы Цзяхуэй и осмотр медицинской среды, соответствующей международным стандартам ухода.
Профессор Ли Хуа, директор онкологического центра Международной больницы Цзяхуэй, и его команда подробно рассказали о плане лечения CAR-T. По сравнению с традиционными методами лечения, CAR-T имеет уникальные преимущества. Во-первых, это высоко персонализированное лечение, которое с помощью генной инженерии регулирует иммунную систему пациента, обеспечивая более точную реакцию на лечение рака. Во-вторых, CAR-T демонстрирует значительно более высокую эффективность в сложных случаях, чего невозможно достичь традиционными методами лечения. Икиоленс имеет общий уровень ответа почти 99% и уровень полного ответа до 82,4%. Что еще более важно, полностью человеческий CAR-T не только поддерживает качество жизни пациента, но и обеспечивает более длительный эффект лечения. Кроме того, однократная инфузионная терапия позволяет достичь быстрых и эффективных результатов, снижая боль и нагрузку в процессе лечения и давая надежду на излечение.
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Второй остановкой для господина Ф. и российских экспертов стало посещение производственного завода первой в мире полностью человеческой BCMA CAR-T терапии, Икиоленс. Господина Ф. и российских экспертов поразило то, что эта выдающаяся терапия была полностью разработана в стране, включая независимую разработку лентивирусного вектора. Завод обладает полной платформой для разработки и собственной производственной базой.
![](https://www.medtourcn.com/wp-content/uploads/2024/08/xcvxcvbvbnvt67561.png)
В конце концов, господин Ф. развеял все свои сомнения и убедился, что китайское полностью человеческое решение BCMA CAR-T является мировым лидером. Он решил пройти лечение в Китае.
Полное очищение от опухолей, поздняя стадия миеломы достигла CR!
В декабре 2023 года, за несколько дней до очередного Рождества спустя пять лет после постановки диагноза, господин Ф. и его семья прибыли в Китай, полные надежд на излечение, чтобы официально начать свой путь с CAR-T. В международной больнице Цзяхуэй в Шанхае господин Ф. прошел тщательное обследование и после выполнения всех требований успешно прошел аферез, процесс сбора Т-клеток. Затем эти клетки были доставлены обратно на фабрику в течение 24 часов для создания точно направленного оружия против рака, специально для господина Ф.
20 января 2024 года он получил лимфодеплетирующую химиотерапию с флударабином и циклофосфамидом.
25 января 2024 года CAR-T клетки, несущие надежду всей семьи господина Ф., были доставлены ему командой аптеки с использованием профессиональной холодовой цепи логистики. После многократных проверок, распаковки и активации небольшой пакетик молочно-белой жидкости был введен обратно в организм господина Ф. Врачи объяснили, что эта жидкость содержит сотни миллиардов Т-клеток “специального назначения”, которые, попав в организм, начнут интенсивную зачистку, полностью уничтожая клетки миеломы.
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Процесс переливания прошел гладко. Что глубоко тронуло господина Ф. и его семью, так это то, что каждый раз, когда он чувствовал беспокойство, медицинская команда держала его за руку, вселяя в него уверенность и силу.
Хотя после переливания возник легкий синдром высвобождения цитокинов (CRS), что является обычным явлением после терапии CAR-T, медицинская команда больницы Цзяхуэй имела большой опыт в лечении этого состояния. Благодаря симптоматическому лечению симптомы улучшились примерно за неделю. На 14-й день после переливания оценка показала, что CAR-T-клетки эффективно расширились в организме господина Ф., достигнув 10^9.
Господин Ф. сказал, что, в отличие от двух болезненных трансплантаций, несмотря на то, что он знал о побочных эффектах терапии CAR-T, медицинская команда четко информировала его о возможных реакциях на разных этапах и заверила, что медицинский персонал немедленно их устранит. В результате он не испытывал никаких беспокойств или страхов.
Перед Китайским Новым годом в 2024 году господин Ф. был выписан и вернулся в Россию для дальнейшего наблюдения в своей стране. Профессор Ли Хуа сказал: “Результаты лечения соответствовали нашим ожиданиям, с значительными улучшениями в ключевых показателях, таких как сывороточный белок M, свободные легкие цепи и симптомы болезни. Все функциональные состояния улучшились.”
В мае 2024 года результаты ПЭТ-КТ показали, что очаги господина Ф. исчезли, и он наконец достиг полной ремиссии (CR). Это означает, что после шестилетней борьбы с множественной миеломой он наконец одержал победу!
Яркое будущее: Китай станет лучшим местом для лечения пациентов с запущенной миеломой!
Сейчас господин Ф. не только возобновил свою счастливую и полноценную жизнь, но и он с женой вернулись к своим любимым профессиям. В настоящее время он занимает должность генерального директора Центра образования в области минеральных ресурсов ЮНЕСКО.
Господин Ф. сказал: “Когда я приехал в Китай и увидел медицинские условия и лично испытал лучшее лечение, я почувствовал глубокую гордость за Китай. К сожалению, Россия пока не может достичь такого уровня ухода. Однако я привезу свои впечатления из Китая в Россию и поделюсь ими. Медицинская система Китая является одной из лучших в мире, и выбор приехать в Китай был абсолютно правильным решением!”
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В интервью жена господина Ф. сказала: “Хотя мы уже вышли на пенсию, у нас обоих есть очень важная работа. Это лечение CAR-T в Китае дало нам очень ценный опыт. У нас появилось больше времени, чтобы выслушивать мысли друг друга, поддерживать друг друга и вместе преодолевать трудности.”
![](https://www.medtourcn.com/wp-content/uploads/2024/08/xcbvcvbcvb3343423424sdfdsf1.png)
Профессор Ли Хуа, директор Международного онкологического госпиталя и заведующий отделением онкологии, сказал в интервью:
“Клинические исследования терапии CAR-T начались в Китае относительно рано. Особенно с 2020 года количество клинических испытаний CAR-T в Китае значительно превысило количество испытаний в США, что дает нам богатый опыт от лабораторных исследований до клинического применения.
Кроме того, лечение CAR-T в Китае более экономически эффективно, предоставляя пациентам более конкурентоспособный вариант.
Самое важное, что в Китае достаточно мощностей для коммерческого производства высокого качества. Пациенты могут быстро получить лечение без ожидания, что крайне важно для больных злокачественными заболеваниями крови, которым требуется своевременное лечение.”
Профессор Ли Хуа, главный врач и главный онколог Международной онкологической больницы Цзяхуй,
Появление CAR-T клеточной терапии принесло новую надежду раковым пациентам по всему миру. Китайская CAR-T терапия отличается высокой эффективностью, хорошей безопасностью, низкой стоимостью и быстрым изготовлением, что дает ей лидирующие преимущества. Несколько международных больниц открыли зеленые коридоры для зарубежных пациентов, что делает Китай лучшим местом лечения для пациентов с множественной миеломой по всему миру!
![](https://www.medtourcn.com/wp-content/uploads/2024/08/1wqeasdsvchjhj341.png)
Использованная литература:
[1] Yuting Yan, et al. Blood Adv. 2019 Oct 8;3(19):2895-2904.[2] 2023 IMS. P-290.
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Redefining Hope for High-Risk RRMM Patients Worldwide: A Singaporean Patient`s Journey to China for Groundbreaking CAR-T Therapy
Redefining Hope for High-Risk RRMM Patients Worldwide: A Singaporean Patient`s Journey to China for Groundbreaking CAR-T Therapy
![Multiple Myeloma](https://www.medtourcn.com/wp-content/uploads/2024/08/微信截图_20240820152652.jpg)
Multiple Myeloma
#MultipleMyeloma #CAR_Therapy #CancerTreatment #HRMM #MM #RRMM #CART
In the fight against multiple myeloma (MM), the last few decades have seen significant advancements, yet the disease remains notoriously difficult to cure, particularly in patients with relapsed/refractory multiple myeloma (RRMM). These patients face enormous challenges, as their options become increasingly limited after multiple lines of therapy have failed. However, hope has emerged in the form of BCMA CAR-T therapy, offering deep remission and long-term survival for those who had nearly lost hope.
One such case is a 58-year-old woman from Singapore, who after exhausting all available treatments in her home country, found new hope in China`s innovative CAR-T therapy. Diagnosed with MM in May 2021 following a month of severe back pain, she underwent a series of treatments including CD38 monoclonal antibodies, immunomodulatory drugs (IMiDs), proteasome inhibitors (PI), and XPO-1 inhibitors. Unfortunately, these therapies failed to halt the progression of her disease, which had become highly resistant to treatment.
In December 2023, she traveled to Beijing Chaoyang Hospital, Capital Medical University, where Professor Chen Wenming took charge of her case. The patient was diagnosed with high-risk MM (IgG-κ type) and admitted to the hospital on November 25, 2023, for CAR-T therapy.
#### The Treatment Journey: A Detailed Overview
Given the patient’s refractory nature and multiple prior treatments, Professor Chen devised a tailored treatment plan to improve her chances of survival and quality of life. In November 2023, her lymphocytes were collected to prepare the CAR-T cells. During this period, she received two cycles of D-PACE (dexamethasone, cisplatin, doxorubicin, cyclophosphamide, and etoposide) chemotherapy in Singapore to control the extramedullary plasmacytoma.
In February 2024, she returned to Beijing for further evaluation, where her condition was assessed as showing minimal response (MR). She was then administered a lymphodepletion regimen of fludarabine and cyclophosphamide on February 29. The following month, she received a transfusion of BCMA CAR-T cells.
Within five days post-transfusion, the patient developed a fever, which peaked at 39°C. Fortunately, her oxygen saturation and heart rate remained normal, and she was diagnosed with Grade 1 cytokine release syndrome (CRS). After symptomatic treatment, her blood counts recovered by day 15, and she was discharged in stable condition.
Two weeks post-CAR-T therapy, her response was evaluated as a very good partial response (VGPR), and by the two-month mark, her condition had improved to complete remission (CR) with minimal residual disease (MRD) negativity.
#### Insights from Leading Experts
Professor Wee Joo Chng, a specialist in high-risk MM, noted the aggressive nature of the patient’s disease, marked by genetic abnormalities like 1q21+ and t(4;14). Despite the use of multiple potent therapies, including KRd, XVd, and Isa-Pd, the patient’s disease continued to progress rapidly. The emergence of the del(17p) mutation further complicated her prognosis, indicating the need for a novel therapeutic approach.
The FUMANBA-1 study has highlighted the effectiveness of China`s indigenous CAR-T product, Equecabtagene Autoleucel, in achieving deep remission and prolonging survival in RRMM patients. This case demonstrated the therapy`s potential to overcome poor prognostic factors and extend the patient’s survival. Notably, the patient experienced only mild CRS and no immune effector cell-associated neurotoxicity syndrome (ICANS) or infections during treatment. At the two-month follow-up, the patient’s condition had improved to CR with MRD negativity, suggesting that Equecabtagene Autoleucel could be a game-changer for high-risk RRMM patients.
#### A New Frontier in CAR-T Therapy
RRMM patients with double-hit characteristics often experience early relapse and progression, leading to shortened survival times. Traditional therapies, including IMiDs, PIs, and monoclonal antibodies, have failed to overcome these poor prognostic factors, indicating the urgent need for novel treatments. Real-world studies have shown that CAR-T therapy offers comparable progression-free survival (PFS) and overall survival (OS) rates in RRMM patients, regardless of high-risk cytogenetic abnormalities.
The FUMANBA-1 study revealed impressive outcomes for Equecabtagene Autoleucel in RRMM patients, with an overall response rate (ORR) of 98.9% and an MRD negativity rate of 97.8% among CAR-T-naive patients. The CR rate was 82.4%, and 81.7% of patients maintained MRD negativity for over a year.
Globally, four CAR-T products are currently available, and a recent study presented at the 2024 European Society for Blood and Marrow Transplantation (EBMT) compared the short- and long-term efficacy of these therapies. The study’s matching-adjusted indirect comparison (MAIC) analysis revealed that Equecabtagene Autoleucel had a 12-month PFS rate of 94.2%, higher than the 75% observed with Ciltacabtagene autoleucel (CARTITUDE-1 study). Furthermore, the 12-month sustained MRD negativity rate for Equecabtagene Autoleucel was 100%, compared to 53.1% for Ciltacabtagene autoleucel.
These findings suggest that Equecabtagene Autoleucel, a Chinese-developed BCMA CAR-T therapy, offers superior long-term efficacy compared to its U.S. counterpart. As the global community celebrates the first anniversary of its approval, Equecabtagene Autoleucel continues to bring hope to RRMM patients worldwide, further solidifying China’s leading role in the field of cellular therapy.
![🎉](https://static.xx.fbcdn.net/images/emoji.php/v9/t8c/1/16/1f389.png)
To assess whether the condition is suitable for CAR-T or clinic therapy, you can submit Advanced Medicine in China for preliminary evaluation!
WhatsApp:+8613717959070
Email: doctor.huang@globecancer.com
#ChinaMedicalInnovation #GlobalHealth #MMResearch #PatientCare #InnovativeMedicine #CellTherapy #MedicalBreakthrough
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**Chinese Biopharmaceuticals: Ushering in a New Era in Nasopharyngeal Carcinoma Treatment, EBV-Specific CAR-T Injection Approved for Phase II Clinical Trials in the US and China**
**Chinese Biopharmaceuticals: Ushering in a New Era in Nasopharyngeal Carcinoma Treatment, EBV-Specific CAR-T Injection Approved for Phase II Clinical Trials in the US and China**
![Nasopharyngeal Carcinoma](https://www.medtourcn.com/wp-content/uploads/2024/08/微信截图_20240814134905.jpg)
Nasopharyngeal Carcinoma
#Nasopharyngeal #Carcinoma #BRG01 #CART #EBVspecific
Biosyngen has announced a milestone achievement: the company’s independently developed BRG01 injection (EBV-specific CAR-T) has received formal written approval from the U.S. Food and Drug Administration (FDA) to conduct pivotal Phase II clinical trials for the treatment of relapsed/metastatic EBV-positive nasopharyngeal carcinoma patients. This is the world’s first original cell drug for solid tumors approved in both the US and China to enter Phase II trials, bringing hope and breakthroughs to the field of solid tumor treatment.
Previously reported, the Center for Drug Evaluation (CDE) of the National Medical Products Administration has agreed to conduct pivotal Phase II clinical trials of BRG01 injection (EBV-specific CAR-T). Patients for the BRG01 US-China Phase I clinical trials completed enrollment by the end of January this year, and all trial participants have received BRG01 reinfusion treatment. The Phase I registered clinical trial of BRG01 has successfully completed DLT (dose-limiting toxicity) observation and efficacy evaluation in 9 patients, all of whom were advanced nasopharyngeal carcinoma patients who had failed at least one treatment, including PD-1 antibody immune checkpoint inhibitors.
The data shows that BRG01 has demonstrated excellent safety and preliminary efficacy: in PET-CT scans, 75% of high-dose patients experienced a local reduction in tumor lesions and a decrease in metabolic activity, with some patients achieving 100% complete remission of tumor lesions. Additionally, BRG01 also demonstrated excellent anti-EB virus efficacy, with a significant reduction of EB virus load in the peripheral blood of patients after reinfusion to normal levels.
These data not only highlight the potential of BRG01 in tumor treatment but also demonstrate its dual advantages in antiviral therapy, laying a solid foundation for future clinical applications. This is believed to be the key reason for the FDA’s approval of BRG01 to enter Phase II clinical trials.
The FDA’s approval not only highly recognizes the preliminary research results of BRG01 injection but also fully affirms Biosyngen’s innovative capabilities and research and development strength in the field of cellular immunotherapy. Biosyngen will take this as an opportunity to accelerate the clinical research process of BRG01 injection, striving to achieve the commercialization of this therapy as soon as possible to bring benefits to nasopharyngeal carcinoma patients worldwide.
Biosyngen’s layout in the field of solid tumor cell therapy goes far beyond this. The company has become a biotech enterprise with three major cellular therapies for both solid and hematological tumors: CAR-T, TCR-T, and TIL. The product pipelines have completed dual submissions and approvals in both the US and China, and the indications for the latter two include a variety of solid tumors such as lung and liver cancer.
Looking to the future, with Biosyngen’s efficient execution and rapid R&D achievements, we have reason to expect more clinical breakthroughs in solid tumor cell drugs in a shorter time, bringing new treatment hopes to patients.
🎉🎉To assess whether the condition is suitable for CAR-T or clinic therapy, you can submit Advanced Medicine in China for preliminary evaluation!
WhatsApp: +8613717959070
Email: doctor.huang@globecancer.com
#Biosyngen #CAR_T #CancerTreatment #NasopharyngealCarcinoma #FDAApproval #ClinicalTrials #MedicalBreakthrough #BiotechInnovation #CancerResearch #Immunotherapy #HealthcareInnovation #CancerHope #SolidTumors #GlobalHealth #CancerCare
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22 Days from Desperation to Rebirth! Chinese CAR-T Therapy Creates Survival Miracle for Thai Multiple Myeloma Patient
22 Days from Desperation to Rebirth! Chinese CAR-T Therapy Creates Survival Miracle for Thai Multiple Myeloma Patient
In July 2017, 58-year-old Ms. M was diagnosed with multiple myeloma. After receiving treatments at the best hospital in Thailand, including PCD, DVD, bortezomib and lenalidomide, autologous hematopoietic stem cell transplantation. The disease rapidly relapsed. Local doctors informed Ms. M’s family that apart from palliative care, they were powerless.
Just as Ms. M was in dire straits, on June 30, 2023, the world’s first fully human BCMA CAR-T therapy – Equecabtagene Autoleucel, was shockingly launched in China, becoming a lifesaving straw for her. Ms. M and her family decided to seek treatment in China.
In September 2023, Professor Li Ping’s team at Shanghai Tongji Hospital developed a personalized Equecabtagene Autoleucel(BCMA CAR-T) therapy plan for Ms. M. What shocked everyone was that the examination results 22 days after CAR-T treatment showed that Ms. M had achieved hematologic CR, meaning that no cancer cells were detected in her blood. Her pain and anemia were also reversed. It was simply a miracle!
Reference:
[1]Yuting Yan, et al. Blood Adv. 2019 Oct 8;3(19):2895-2904.
[2] 2023 IMS. P-290.
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Nature Communications | Chinese Medical Team Innovates CAR-T Therapy to Bring New Hope for AML Treatment
Nature Communications | Chinese Medical Team Innovates CAR-T Therapy to Bring New Hope for AML Treatment
![AML](https://www.medtourcn.com/wp-content/uploads/2024/08/微信截图_20240812145103.jpg)
AML
In the field of hematological malignancies, the treatment of acute myeloid leukemia (AML) has long been a challenge in the medical community. Particularly for relapsed or refractory patients, the limitations of traditional treatments have increased the urgent need for new therapies. With the advancements in immunotherapy technology, the continuous updating of CAR-T cell therapy has brought new possibilities for the treatment of AML.
Recently, a study titled “CAR-T Cells with C-JUN Overexpression in Acute Myeloid Leukemia: Preclinical Features and Phase I Trial” was published in the journal Nature Communications. This study comprehensively explores the potential optimization mechanisms of CAR-T therapy in AML and was jointly completed by doctors and professors from three top hospitals in China.
During an interview, the Chinese medical team stated that in designing this study, they focused on the major obstacles in CAR-T cell therapy for AML. Although CD33, a highly expressed target, has been extensively explored in multiple studies, safety and efficacy remain challenges. The study found that high expression of CD155 affects the ERK signaling pathway, thereby hindering the effective expansion of CD33. To address this challenge, the research team ultimately selected the overexpression of C-JUN to enhance the exhaustion resistance of CAR-T cells by screening ERK pathway genes. Preliminary results from the clinical trial showed that this overexpressed CD33 CAR-T cell exhibited significant advantages in antitumor function.
Despite the progress, the challenges in CAR-T therapy for AML treatment were also emphasized, including the balance between high efficacy and low toxicity, the expansion of CAR-T cells in myeloid leukemia cells, and the affinity of antibody binding. Subsequent research will focus more on addressing these key issues to enable more patients to benefit from CAR-T therapy.
The Chinese clinical trials revealed some key findings of CAR-T therapy, such as the effectiveness of the bridging transplant strategy and the remarkable efficacy of CD33 CAR-T cells derived from transplant donors. These studies not only provide new insights into the application of CAR-T therapy in AML but also offer references for the optimization of therapies targeting other antigens.
The Chinese medical team will continue to conduct in-depth research around the three core issues of toxicity, expansion, and antigen binding, aiming to overcome challenges and enable more patients to benefit from the breakthrough results of CAR-T cell therapy.
����To assess whether the condition is suitable for CAR-T or clinic therapy, you can submit Advanced Medicine in China for preliminary evaluation!
WhatsApp: +8613717959070
Email: doctor.huang@globecancer.com
#CAR_TCellTherapy #AcuteMyeloidLeukemia #AMLResearch #ImmunotherapyAdvancements #ChineseMedicalInnovation #CancerTreatment #MedicalBreakthrough #NatureCommunications #OncologyResearch #HematologicalMalignancies
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Chinese Medical Team Research: 64.6% Complete Remission Rate, Over Half of Patients Progression-Free for More Than Two Years! Targeted Therapy Combined with Chemotherapy is Safe and Effective as First-Line Treatment for Lymphoma
**Chinese Medical Team Research: 64.6% Complete Remission Rate, Over Half of Patients Progression-Free for More Than Two Years! Targeted Therapy Combined with Chemotherapy is Safe and Effective as First-Line Treatment for Lymphoma**
![Lymphoma](https://www.medtourcn.com/wp-content/uploads/2024/08/微信截图_20240809120604.jpg)
Lymphoma
Peripheral T-cell lymphoma (PTCL) is a group of highly aggressive and heterogeneous diseases with poor prognosis. The standard CHOP regimen (cyclophosphamide, doxorubicin, vincristine, and prednisone) is widely used as first-line treatment for PTCL. Previous studies have confirmed the safety and efficacy of combining various targeted drugs with CHOP (CHOPX) for PTCL treatment. However, there are multiple PTCL subtypes with different mutations, such as TP53, TET2, KMT2D, and CREBBP/EP300, and evidence is still lacking regarding the effectiveness of these combined treatment regimens in patients with specific genetic mutations.
Recently, a Chinese study published in *The Lancet Regional Health–Western Pacific* showed that selecting targeted therapies based on specific genetic mutations, combined with CHOP as a first-line treatment for PTCL, demonstrated good efficacy and safety. Compared to standard CHOP, CHOPX treatment achieved a higher complete remission rate and longer progression-free survival. This study was conducted by a Chinese medical team.
This was an open-label, multi-center, non-randomized, external-controlled phase 2 clinical trial (code-named GUIDANCE-03) conducted across seven medical centers in China. The trial compared the efficacy and safety of targeted drug combinations based on specific genetic mutations with CHOP (CHOPX) versus CHOP alone in newly diagnosed PTCL patients.
A total of 96 newly diagnosed PTCL patients (aged ≥18 years, median age 63 years) were enrolled in the study, with 48 patients in each group (CHOPX and CHOP). Genetic sequencing results showed that 93 patients (96.9%) carried genetic mutations. Patients in the CHOPX group received standard CHOP treatment during the first treatment cycle. Starting from the second cycle, targeted drugs were added based on the patient’s specific genetic mutations: decitabine (for TP53 mutations), azacitidine (for TET2/KMT2D mutations), chidamide (for CREBBP/EP300 mutations), and lenalidomide (for patients without these mutations), with a total of six treatment cycles. Patients in the CHOP group received six cycles of CHOP treatment.
The primary endpoint of the study was the complete remission rate (CRR) at the end of treatment. Secondary endpoints included overall response rate (ORR), progression-free survival (PFS), overall survival (OS), and safety. The analysis results showed:
– At the end of treatment, the CRR of the CHOPX group was superior to that of the CHOP group. Compared to the CHOP group, the CHOPX group saw an approximate 30% improvement in CRR (64.6% vs. 33.3%, OR 0.27, 95% CI 0.12-0.64; P=0.004), achieving the primary endpoint of the study.
– For secondary endpoints, the ORR of the CHOPX group was better than that of the CHOP group (66.7% vs. 52.1%).
– During a median follow-up period of 24.3 months, the median PFS of the CHOPX group was significantly longer than that of the CHOP group (25.5 months vs. 9.0 months; HR 0.57, 95% CI 0.34-0.98; P=0.041), with a 43% reduction in the risk of disease progression or death. The 2-year PFS rates for the two groups were 53.2% (95% CI 38.7-67.7) and 28.0% (95% CI 13.6-42.3), respectively.
In terms of OS, the median OS for the CHOPX group has not yet been reached, while the median OS for the CHOP group was 30.9 months. The CHOPX group showed a trend toward improved OS, but the current statistical results are not significant (HR 0.55, 95% CI 0.28-1.10; P=0.088). The 2-year OS rates for the two groups were 68.0% and 60.8%, respectively.
Regarding safety, neutropenia was the most common adverse event in both the CHOPX and CHOP groups (82% in the CHOPX group and 73% in the CHOP group). The most common grade 3-4 hematologic adverse event in both groups was neutropenia, and the most common grade 3-4 non-hematologic adverse event was infection. In the CHOPX group, 65% (31 patients) reported neutropenia, but no patients experienced prolonged neutropenia (>14 days) or required dose adjustments of the targeted drugs, and 10% (5 patients) experienced infections. In the CHOP group, these proportions were 52% (25 patients) and 4% (2 patients), respectively.
In conclusion, the study results indicate that different targeted drugs combined with CHOP demonstrate good efficacy and safety. These findings provide preliminary evidence supporting the use of CHOPX as a first-line treatment for PTCL patients with different genetic mutations, and suggest that biomarker-driven treatment strategies are feasible and worth further exploration in the future.
![🎉](https://static.xx.fbcdn.net/images/emoji.php/v9/t8c/1/16/1f389.png)
To assess whether the condition is suitable for CAR-T or clinic therapy, you can submit Advanced Medicine in China for preliminary evaluation!
WhatsApp: +8613717959070
Email: doctor.huang@globecancer.com
#CancerResearch #LymphomaTreatment #PTCL #TargetedTherapy #Chemotherapy #MedicalBreakthrough #Oncology #ClinicalTrials #ChineseMedicine #CancerSurvivorship #HealthcareInnovation #PrecisionMedicine #CancerTreatment #MedicalResearch #CHOPTherapy #OncologyUpdates #CancerCare
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Overcoming Challenges and Embracing New Life! – Breakthrough Progress of Eque-cel in the Treatment of Refractory Multiple Myeloma
### Overcoming Challenges and Embracing New Life! – Breakthrough Progress of Eque-cel in the Treatment of Refractory Multiple Myeloma
![Multiple Myeloma](https://www.medtourcn.com/wp-content/uploads/2024/08/微信截图_20240808175732.jpg)
Multiple Myeloma
In the treatment of multiple myeloma (MM), how do we find new breakthroughs for patients who have not achieved complete remission (CR) after multiple rounds of chemotherapy? Research by Chinese medical professors has provided an exciting answer: Eque-cel (BCMA CAR-T therapy).
**Patient Background:**
This 58-year-old female patient was initially admitted to the hospital due to numbness and pain in both lower limbs and was eventually diagnosed with multiple myeloma. Despite receiving various treatment regimens, including VRD and SVPD, the results were unsatisfactory, and complete remission was not achieved. Faced with refractory characteristics, the doctors decided to try a more innovative treatment plan—CAR-T cell therapy.
**Treatment Process:**
In September 2023, the patient began peripheral blood mononuclear cell collection, followed by bridging therapy, and in November 2023, she received the Eque-cel infusion. Remarkably, just one month later, the patient achieved hematologic complete remission (CR) with minimal residual disease (MRD) negativity. After six months of follow-up, the patient maintained this excellent therapeutic effect.
**Professor’s Insights:**
Chinese medical professors pointed out that the advent of Eque-cel has brought new hope to refractory MM patients. The drug demonstrated significant efficacy in the FUMANBA-1 study: the overall response rate was as high as 98.9%, with 82.4% achieving complete remission, and 97.8% of patients achieving MRD negativity. The 12-month sustained MRD negativity rate reached 81.7%, and the PFS rate was 85.5%.
This outstanding result proves the significant advantage of Eque-cel in improving the depth of remission for MM patients, bringing hope for long-term survival to many refractory patients.
**Future Outlook:**
As the application and research of Eque-cel continue, we look forward to it providing better treatment options and survival opportunities for more MM patients. This new treatment plan is bringing a ray of hope to this stubborn disease and providing valuable experience for clinical experts worldwide.
**Stay Tuned:**
We will continue to follow the latest developments and research progress of Eque-cel, looking forward to its greater role globally, bringing hope and blessings to more patients.
![🎉](https://static.xx.fbcdn.net/images/emoji.php/v9/t8c/1/16/1f389.png)
To assess whether the condition is suitable for CAR-T or clinic therapy, you can submit Advanced Medicine in China for preliminary evaluation!
WhatsApp:+8613717959070
Email: doctor.huang@globecancer.com
#MultipleMyeloma #CARTTherapy #MedicalBreakthrough #EqueCel #CancerTreatment #MedicalResearch #Hematology #PatientCare #OncologyInnovation #HopeForPatients #BCMA #CART #MM #RRMM
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Chinese Medical Team: Long Survival and Significant Benefits with BCMA CAR-T Treatment for RRMM: A 5-Year Outlook
**Chinese Medical Team: Long Survival and Significant Benefits with BCMA CAR-T Treatment for RRMM: A 5-Year Outlook**
![RRMM](https://www.medtourcn.com/wp-content/uploads/2024/08/微信截图_20240805175528.jpg)
RRMM