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2 months ago Lymphoma

**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

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


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2 months ago Myeloma , CAR-T

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

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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2 months ago patient story

Seeking Medical Treatment Abroad: The Best CAR-T Therapy is in China! The First Russian Multiple Myeloma Patient Successfully Achieves Complete Tumor Clearance and CR!

**Seeking Medical Treatment Abroad: The Best CAR-T Therapy is in China! The First Russian Multiple Myeloma Patient Successfully Achieves Complete Tumor Clearance and CR!**

patient story

patient story

Over the five years following his diagnosis of high-risk multiple myeloma, Mr. F endured relentless pain. Despite undergoing various chemotherapy regimens and two transplants, he could never completely escape the nightmare of unpredictable tumor recurrence and progression. Fortunately, by the end of 2023, his condition temporarily stabilized. Accompanied by top hematology experts from Russia, Mr. F traveled to China to receive CAR-T therapy, achieving optimal results with complete tumor eradication and CR (complete remission).

Achieved CR! In February 2024, Mr. F and his family successfully returned to Russia to resume their happy lives.

(Note: To protect patient privacy, pseudonyms are used in the text, and the medical details and treatment process have been slightly modified.)

**Common Back Pain Turned Out to Be High-Risk Multiple Myeloma**

Mr. F, 63, is the vice principal of a technical college in St. Petersburg, Russia. He has a successful career and a happy family with his wife, one son, and two daughters. In the months leading up to Christmas 2017, Mr. F experienced worsening back pain, with severe pain in the lumbar region. Accompanied by his family, he went to the hospital for a thorough examination. The final diagnosis was multiple myeloma, with osteolytic lesions in more than three areas. The doctor informed Mr. F that, based on the comprehensive assessment of various test results, his myeloma was classified as high-risk (IgG-type, DS-Stage IIIA, ISS-Stage II), making it difficult to treat, prone to relapse, and with a poor prognosis. This devastating news struck suddenly, plunging the entire family into shock and panic. In an interview, Mr. F said, “In Chinese culture, Confucius said, ‘When Heaven is about to place a great responsibility on a man, it always first frustrates his spirit,’ viewing it as a life test. In Western culture, it is seen as God’s punishment, a trial one must endure, with the outcome entirely dependent on how one faces these challenges. I must choose to fight!”

**Relapse and Progression: The Unshakeable Nightmare for Multiple Myeloma Patients**

After two days of shock and panic, Mr. F decided to pull himself together and seek the best treatment to fight the tumor. Mr. F and his family consulted many doctors and clinics in Spain, Munich, and Heidelberg. Upon learning that CAR-T therapy had remarkable curative effects on hematologic malignancies, they felt a glimmer of hope, which was soon extinguished. At that time, very few countries offered CAR-T therapy, mostly in developed nations, and the exorbitant cost of nearly a million dollars made it unaffordable even for the well-off Mr. F. To control the disease as quickly as possible, Mr. F underwent traditional CVD therapy in Russia at the beginning of 2018, followed by his first autologous bone marrow transplant, achieving partial remission (PR). Unfortunately, just ten months later, his multiple myeloma relapsed. After switching to a second-line chemotherapy regimen, he underwent a second autologous bone marrow transplant. Despite receiving the most aggressive treatment and enduring life-threatening side effects, tumor lesions persisted in his body, like a ticking time bomb that could explode at any moment. Although maintenance therapy temporarily stabilized the disease, Mr. F and his family remained vigilant. They knew that high-risk myeloma was likely to relapse and progress again in the short term. If the disease worsened once more, they would face a desperate situation with no available treatments.

**Global Comparison Shows the Best CAR-T Therapy is in China!**

To completely rid himself of cancer and escape the nightmare of constant relapse and deterioration, five years later, Mr. F and his family once again sought the possibility of a cure through CAR-T therapy worldwide. They conducted extensive research on the CAR-T therapies already on the market and consulted numerous hospitals and experts in Europe, including in India and Israel. To his surprise, despite five years passing, there had been no significant progress in these countries. Almost every expert mentioned that Chinese hospitals had made tremendous advancements in the CAR-T field, surpassing even those in Europe and the United States. Especially for multiple myeloma, on June 30, 2023, China introduced the world’s first fully human BCMA CAR-T therapy, Iquilence. Mr. F and his attending physician immediately contacted Shanghai Jiahui International Hospital in China for an initial remote consultation. Jiahui Hospital, an internationally aligned oncology center with a professional multidisciplinary MDT team, conducted a preliminary evaluation. They concluded that the Iquilence (BCMA CAR-T) treatment plan would be most beneficial and developed a comprehensive plan, addressing all questions and concerns of Mr. F and the Russian experts, ultimately reaching a consensus on the treatment plan.

Professor Li Hua, Director of Oncology at Jiahui International Cancer Center, and his team of Russian hematology experts discussed Mr. F’s treatment plan. Although Mr. F was somewhat aware of China’s medical advancements, he couldn’t imagine that China’s healthcare had surpassed that of the developed Western countries. Therefore, in November 2023, Mr. F’s attending physician, a renowned Russian hematology expert, accompanied him to China to evaluate the feasibility of Chinese CAR-T therapy on-site. Their first stop upon arriving in China was to meet with Jiahui Hospital’s international multidisciplinary treatment team and tour the medical environment that adheres to international nursing standards.

Professor Li Hua, Director of Jiahui International Cancer Center, and his team provided a detailed introduction to the CAR-T treatment plan. Compared to traditional treatments, CAR-T has unique advantages. Firstly, it is a highly personalized treatment that adjusts the patient’s immune system through genetic engineering, providing a more precise response to cancer treatment. Secondly, CAR-T shows significantly higher efficacy in complex cases, which traditional treatments cannot achieve. Iquilence has an overall response rate of nearly 99% and a complete response rate of up to 82.4%. More importantly, fully human CAR-T not only maintains the patient’s quality of life but also provides more durable treatment effects. Additionally, a one-time infusion treatment achieves rapid and effective results, reducing the pain and burden during the treatment process and bringing hope for a cure.+

The second stop for Mr. F and the Russian experts was a visit to the production facility of the world’s first fully human BCMA CAR-T therapy, Iquilence. Mr. F and the Russian experts were impressed to learn that this exceptional therapy was not only entirely developed in-house, but the lentiviral vector was also independently developed. The facility boasts a complete end-to-end development platform and a self-built manufacturing base.

Finally, Mr. F overcame all his concerns and was convinced that China’s fully human BCMA CAR-T solution was world-leading. He decided to undergo treatment in China.

All Tumors Cleared for the First Time, Advanced Myeloma Achieves CR!

In December 2023, just before another Christmas five years after his diagnosis, Mr. F and his family arrived in China, full of hope for a cure, to officially begin his CAR-T journey. At Shanghai Jiahui International Hospital, Mr. F underwent thorough examinations, and after meeting all the requirements, he successfully underwent apheresis, the process of collecting T cells. These cells were then transported back to the factory within 24 hours to create a precisely targeted anti-cancer weapon tailored for Mr. F.

On January 20, 2024, he received lymphodepleting chemotherapy with fludarabine and cyclophosphamide.

On January 25, 2024, the CAR-T cells, carrying the hopes of Mr. F’s entire family, were transported to him by the pharmacy team using professional cold chain logistics. After multiple inspections, unpacking, and reactivation, a small bag of milky white liquid was infused back into Mr. F. The doctors explained that this liquid contained hundreds of billions of “special forces” T cells, which, once in the body, would begin an intense sweep to eradicate the myeloma cells completely.

The infusion process went smoothly. What deeply moved Mr. F and his family was that whenever he felt anxious, the medical team would hold his hand, giving him confidence and strength.

Although a mild cytokine release syndrome (CRS), which is common after CAR-T therapy, occurred post-infusion, the medical team at Jiahui Hospital was very experienced in handling this. With symptomatic treatment, the symptoms improved in about a week. On the 14th day after the infusion, the evaluation showed that the CAR-T cells had expanded effectively in Mr. F’s body, reaching 10^9.

Mr. F said that, unlike the two painful transplant experiences, despite knowing that CAR-T therapy has side effects, the medical team clearly informed him about the reactions he might have at different stages and assured him that the medical staff would address them immediately. As a result, he felt no concerns or fears.

Before the Chinese New Year in 2024, Mr. F was discharged and returned to Russia for further follow-up in his home country. Professor Li Hua said, “The treatment results met our expectations, with significant improvements in key indicators such as serum M protein, free light chains, and disease symptoms. All functional statuses have improved.”

In May 2024, the PET-CT results showed that Mr. F’s lesions had disappeared, and he finally achieved complete remission (CR). This means that after battling multiple myeloma for six years, he has finally won!

A Brighter Future: China Will Become the Best Treatment Destination for Advanced Myeloma Patients!

Now, Mr. F not only resumes his happy and fulfilling life, but he and his wife have also returned to their beloved careers. He currently serves as the General Manager of the UNESCO Mineral Resources Education Center.

Mr. F said, “When I came to China and saw the medical conditions and experienced the best care firsthand, I felt a deep sense of pride for China. It is regrettable that Russia is currently unable to achieve this level of care. However, I will bring my experiences here back to Russia and share them. China’s medical system is world-leading, and choosing to come to China was the right decision!”

In an interview, Mr. F’s wife said, “Although we are past retirement age, we both have very important careers. This CAR-T treatment in China has given us a very precious experience. We have more time to listen to each other’s thoughts, support each other, and get through difficult times together.”

Professor Li Hua, Director of the International Oncology Hospital and Director of the Department of Oncology, said in an interview:

“Clinical research on CAR-T therapy started relatively early in China. Especially since 2020, the number of CAR-T clinical trials in China has far surpassed that in the United States, giving us extensive experience from laboratory research to clinical application.

Moreover, CAR-T treatment in China is more cost-effective, providing patients with a more competitive option.

Most importantly, China has sufficient commercial-quality production capacity. Patients can receive treatment quickly without waiting, which is crucial for those with malignant hematologic diseases who need timely treatment.”

Professor Li Hua, Director of Oncology at Jiahui International Hospital,

The emergence of CAR-T cell therapy has brought new hope to cancer patients worldwide. China’s CAR-T therapy offers outstanding efficacy, good safety, low cost, and rapid preparation advantages. Several international hospitals have opened green channels for overseas patients, making China the best treatment destination for global late-stage multiple myeloma patients!

References:

[1] Yuting Yan, et al. Blood Adv. 2019 Oct 8;3(19):2895-2904.[2] 2023 IMS. P-290.


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2 months ago Myeloma

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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2 months ago Leukemia

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

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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2 months ago Myeloma

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

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.

🎉🎉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


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3 months ago CAR-T

Expert Perspective: Side Effects and Management of CAR-T Therapy for a Thai Patient

**Expert Perspective: Side Effects and Management of CAR-T Therapy for a Thai Patient**

At the Hematology Department of Shanghai Tongji Hospital, Dr. Li Ping, the chief physician for the elderly Thai patient Ms. P, provided a detailed overview of the patient’s multiple myeloma condition and treatment journey. After experiencing multiple treatments and relapses in Thailand, the patient ultimately chose and trusted CAR-T therapy in China. Dr. Li highlighted that the most common side effect is cytokine release syndrome (CRS), which manifests as fever, hypotension, and difficulty breathing. While most CRS cases are mild to moderate, severe CRS can be life-threatening. She also emphasized that through scientific management, the team’s extensive experience, and the low immunogenicity of the fully human CAR-T product FUCASO, the side effects of CAR-T therapy can be effectively controlled, offering the patient hope for a cure.

We will continue to follow up on this patient’s treatment progress and provide updates.

#CARTherapy #MultipleMyeloma #FUCASO #Equecel #TongjiHospital #Shanghai #MedicalInnovation #CancerTreatment #Hematology #PatientJourney #Immunotherapy


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3 months ago Lymphoma

Chinese Medical Team: Sequential CD20 CAR-T Therapy Outperforms Salvage Chemotherapy for CD19 CAR-T Resistant B-Cell Lymphoma Patients

## Chinese Medical Team: Sequential CD20 CAR-T Therapy Outperforms Salvage Chemotherapy for CD19 CAR-T Resistant B-Cell Lymphoma Patients

CAR-T therapy

CAR-T therapy

In recent years, with the application of CD19 CAR-T in refractory/relapsed B-cell lymphoma, we have encountered patients for whom CD19 CAR-T therapy was ineffective or who relapsed shortly after initial success. While research continues to explore factors that may affect the efficacy of CD19 CAR-T therapy, doctors and scholars are actively seeking more effective treatments for these patients. In June of this year, Professor Ke Xiaoyan and Professor Hu Kai from the Lymphoma and Myeloma Department of Beijing Gaobo Hospital published an article titled “Salvage CD20-SD-CART Therapy in Aggressive B-Cell Lymphoma After CD19 CART Treatment Failure” in the journal *Frontiers in Oncology*. This study provides new insights for treating B-cell lymphoma patients who have failed CD19 CAR-T therapy.

### Efficacy of Sequential CD20 CAR-T Therapy Exceeds Salvage Chemotherapy Post-CD19 CAR-T Failure

Regarding the innovation of this research, Professor Hu Kai pointed out that international scholars currently focus on chemotherapy (including new drugs), targeted drug therapy, and allogeneic hematopoietic stem cell transplantation for B-cell lymphoma patients who have failed CD19 CAR-T therapy. However, there is limited data on switching targets for a second CAR-T therapy. Our team summarized the treatment outcomes of 93 B-cell lymphoma patients who failed CD19 CAR-T therapy. Among them, 54 out of 93 (58%) chose sequential CD20-targeted second CAR-T therapy, and 39 out of 93 (42%) opted for chemotherapy combined with new drugs and targeted therapy. The results showed that the complete remission rate (CRR) in the sequential CD20 CAR-T group was significantly higher than in the chemotherapy group, with rates of 27.8% and 7.9%, respectively (P=0.03).

After a median follow-up period of 18.54 months, the sequential CD20 CAR-T group showed a significantly longer median progression-free survival (4.04 months vs. 2.27 months, P=0.0032) and median overall survival (8.15 months vs. 3.02 months, P<0.0001) compared to the non-CAR-T group. Multivariate analysis further confirmed that sequential CD20-targeted second CAR-T therapy is an independent factor associated with improved overall survival (HR 0.28, 95%CI: 0.16-0.51; P<0.0001) and progression-free survival (HR 0.46, 95%CI: 0.27-0.8; P=0.005).

### Safety of Sequential CD20-Targeted Second CAR-T Therapy

The study noted that the incidence of severe CRS (≥ grade 3) and ICANS (≥ grade 3) was relatively low during the sequential CD20-targeted second CAR-T therapy, at 9.2% and 7.4%, respectively, with complete recovery after treatment. Other adverse reactions were also controllable.

### Factors Affecting the Efficacy of Second CAR-T Therapy

We used a univariate regression model to evaluate factors affecting the response to sequential CD20-targeted second CAR-T therapy. An IPI score of ≥3 (OR 0.3, 95%CI: 0.10-0.93, P=0.04) was significantly associated with a lower overall response rate (ORR). Additionally, ECOG PS ≥3 (HR 3.12, 95%CI: 1.23-7.94, P=0.02) was associated with decreased progression-free survival and overall survival.

### Study Commentary

Professor Ke Xiaoyan highlighted that the Lymphoma and Myeloma Department at Beijing Gaobo Hospital has accumulated extensive experience with CAR-T therapy in recent years. As the number of CAR-T cases increases in real-world scenarios, CD19 CAR-T may cure half of the patients with relapsed/refractory B-cell lymphoma. For patients who fail CD19 CAR-T therapy, clinical problems become more complex. Our experience suggests that selecting CD20-targeted second CAR-T therapy based on the expression of surface antigens on recurrent tumors can still achieve better results than salvage chemotherapy, extend patient survival, and maintain controllable safety. Tumor burden and the patient’s physical condition remain factors affecting the efficacy of sequential CD20 CAR-T 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-T #CancerTreatment #LymphomaResearch #MedicalAdvancements #CD19CAR-T #CD20CAR-T #Oncology #ClinicalResearch #CancerSurvivorship #MedicalBreakthroughs


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3 months ago Myeloma , CAR-T

2024 EBMT : China’s First RRMM CAR-T Therapy Equecabtagene Autoleucel: Efficacy Unaffected by Patients’ Baseline sBCMA Plasma Levels

2024 EBMT : China’s First RRMM CAR-T Therapy Equecabtagene Autoleucel: Efficacy Unaffected by Patients’ Baseline sBCMA Plasma Levels

RRMM

RRMM

In recent years, CAR-T cell therapy targeting BCMA has emerged as a groundbreaking treatment for multiple myeloma, offering new hope to patients. At the 50th European Society for Blood and Marrow Transplantation (EBMT) Annual Meeting, held from April 14-17, 2024, in Glasgow, the team led by Professor Qiu Lugui presented the latest subgroup analysis results from the FUMANBA-1 study (Abstract OS10-04) on China’s first BCMA-targeted CAR-T therapy, Iquilencel (CT103A).

BCMA (B-cell maturation antigen) is a promising therapeutic target for multiple myeloma (MM), with soluble BCMA (sBCMA) levels in the blood reflecting tumor burden. High sBCMA levels can interfere with the effectiveness of BCMA-targeted therapies, including CAR-T, by competing with cell-surface BCMA for binding, which can lead to reduced efficacy. In contrast, Iquilencel has been designed to minimize the impact of sBCMA on treatment outcomes through careful selection of its single-chain variable fragment (scFv).

The FUMANBA-1 phase II study (NCT05066646) in Chinese patients with relapsed/refractory multiple myeloma (RRMM) has demonstrated that Iquilencel can induce deep and durable responses, with a complete response (CR) rate of 82.4% and a 12-month progression-free survival (PFS) rate of 85.5%. This study aimed to explore whether baseline serum sBCMA levels affect clinical outcomes following Iquilencel infusion.

### Study Methods and Results

The study used enzyme-linked immunosorbent assay (ELISA) to measure serum sBCMA levels and digital droplet PCR (ddPCR) to monitor CAR transgene copy numbers in patients’ peripheral blood. Baseline serum sBCMA levels were classified into high (≥225.1 ng/mL) and low (<225.1 ng/mL) groups. Results showed that high sBCMA levels were significantly associated with high tumor burden, advanced R-ISS and DS stages, and high BCMA expression. However, there were no significant differences in CAR-T cell expansion, AUC (Area Under the Curve) during the first 28 days, or cell persistence between the high and low sBCMA groups.

Patients with high baseline sBCMA levels had overall response rates (ORR) and ≥CR rates of 100% and 80%, respectively, compared to 97.8% and 84% in the low sBCMA group. Analysis showed no significant correlation between baseline characteristics (including sBCMA levels) and CR/sCR achievement. Additionally, there were no significant differences in minimal residual disease (MRD) negativity rates, 18-month sustained MRD negativity rates, PFS, and overall survival (OS) between the two groups.

### Conclusion

The findings from the FUMANBA-1 study indicate that Iquilencel’s efficacy is not influenced by baseline sBCMA levels, making it a universally applicable and promising treatment option for RRMM patients. Its unique fast-dissociation and low-exhaustion properties, similar to those of healthy T-cell receptors, enable Iquilencel to remain effective and persistent in patients’ bodies regardless of sBCMA levels.

Professor Qiu Lugui from the Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences, and Professor Li Chunrui from Tongji Hospital, Huazhong University of Science and Technology, noted, “sBCMA is an important biomarker of tumor burden in multiple myeloma and a key factor influencing prognosis. Accumulation of sBCMA can inhibit the function of BCMA CAR-T cells. However, our study shows that Iquilencel can overcome the challenges posed by high baseline sBCMA levels, providing significant and lasting responses for RRMM patients.”

These results underscore Iquilencel as an ideal treatment choice for RRMM, offering hope for more effective and long-lasting therapeutic outcomes.

 

🎉🎉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

#EBMT2024 #CAR_T #MultipleMyeloma #Iquilencel #EquecabtageneAutoleucel #sBCMA #CancerResearch #Immunotherapy #MedicalBreakthrough #Biopharmaceuticals


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3 months ago Solid tumor , CAR-T

Successful CAR-T Treatment for Advanced Gastric Cancer! Beneficial for Liver Cancer, Brain Tumors, Pancreatic Cancer, with a DCR of 96.1%

Successful CAR-T Treatment for Advanced Gastric Cancer! Beneficial for Liver Cancer, Brain Tumors, Pancreatic Cancer, with a DCR of 96.1%

Gastric Cancer

Gastric Cancer

According to a report by People’s Daily on April 6, 2023, China has achieved another milestone in the CAR-T field. Recently, China Jiangxi Province successfully completed its first case of CAR-T cell therapy for solid tumors. This not only represents a significant breakthrough in new cancer treatment technologies in Jiangxi but also marks a major advancement in China’s CAR-T research and application.

China’s Jiangxi Achieves a Breakthrough in CAR-T Therapy for Solid Tumors

The patient, an advanced gastric cancer patient, had previously undergone chemotherapy combined with immune checkpoint inhibitor (ICI) treatment, but the disease was not well controlled. The tumor had widely metastasized to the abdominal cavity and multiple bones, accompanied by complications such as anorexia, abdominal distension, and severe recurrent reduction in blood cells, making the patient unable to tolerate chemotherapy.

With no other options, the patient received CAR-T cell reinfusion therapy on March 20, 2023, at the Oncology Center of The Second Affiliated Hospital of Nanchang University, with substantial support from the team at Peking University Cancer Hospital (Beijing Cancer Hospital). Fortunately, the patient has safely passed the peak period of cytokine release syndrome (CRS). Compared to before CAR-T treatment, tumor markers have decreased to normal levels, and the patient’s physical condition, mental state, and symptoms (such as abdominal distension and anorexia) have significantly improved. This marks a “zero breakthrough” for CAR-T cell therapy in solid tumors in Jiangxi Province of China, leaving a significant mark in the field of CAR-T research and application in China.

Peking University Cancer Hospital Showcases CT041 CAR-T at 2024 ASCO Conference with a Disease Control Rate of 96.1%

In addition to this fortunate case, the research team from Peking University Cancer Hospital showcased a domestically developed CAR-T product named “satri-cel” (development code CT041) at the recent 2024 American Society of Clinical Oncology (ASCO) conference. Satri-cel is a CAR-T cell therapy targeting Claudin18.2 (CLDN18.2) and is the only CLDN18.2 CAR-T cell therapy in the world approved for clinical trials (IND) in both China and the United States, targeting digestive tract tumors such as gastric cancer and pancreatic cancer.

The final results of the Phase 1 clinical trial (NCT03874897) were presented in an oral report at this conference. In patients with gastric cancer/gastroesophageal junction adenocarcinoma (GC/GEJ) treated with satri-cel monotherapy, the results showed a disease control rate (DCR) of 96.1% (49/51), an objective response rate (ORR) of 54.9% (28/51), a median overall survival (mOS) of 9.0 months, a median progression-free survival (mPFS) of 5.8 months, and a median duration of response (mDOR) of 6.4 months.

As early as May 2022, the team at Peking University Cancer Hospital had reported clinical cases of CT041 treating gastric cancer. A 57-year-old gastric cancer patient (Pt08), who had previously undergone three treatments, including PD-1 antibody, showed improvement after receiving CT041 CAR-T cell therapy. Visual inspection and CT scans indicated that the patient’s condition improved, with reduced umbilical tumor lesions, and the efficacy was still ongoing as of the date of the report.

🎉🎉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

#CART #CancerTreatment #GastricCancer #LiverCancer #BrainTumor #PancreaticCancer #MedicalBreakthrough #Oncology #Jiangxi #ChinaBiotech #CancerResearch #ASCO2024 #PekingUniversityCancerHospital #InnovativeTherapy #MedicalAdvancements #HealthNews


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3 months ago Myeloma

IMWG Releases 2024 RRMM CAR-T Guidelines: Equecabtagene Autoleucel Becomes China’s First Included CAR-T Therapy

###IMWG Releases 2024 RRMM CAR-T Guidelines: Equecabtagene Autoleucel Becomes China’s First Included CAR-T Therapy

IMWG

IMWG

###EquecabtageneAutoleucel: Leading China’s CAR-T Therapy to Global Breakthroughs

In the latest guidelines released by the International Myeloma Working Group (IMWG) in 2024, Equecabtagene Autoleucel, a CAR-T therapy independently developed in China, has been officially included. This marks the first and only Chinese CAR-T product included in the global treatment guidelines for relapsed and refractory multiple myeloma (RRMM). This milestone signifies a major breakthrough for China in the field of CAR-T therapy and brings new hope to RRMM patients worldwide.

####CARTTherapy: A New Hope for Multiple Myeloma Patients

Multiple myeloma (MM) is a challenging blood cancer to treat, with approximately 176,404 new cases and 117,077 related deaths globally in 2020. Traditional therapies have limited effectiveness for relapsed and refractory MM patients. The emergence of CAR-T cell therapy has brought significant treatment progress for this group. CAR-T therapy reprograms the patient’s own T cells to recognize and kill cancer cells, achieving remission rates of 73%-98%.

#### Equecabtagene Autoleucel: A Unique Fully Human CAR-T Product

Equecabtagene Autoleucel is the only fully human CAR-T product included in the “2024 IMWG RRMM CAR-T Guidelines.” Compared to the other two included CAR-T products, which are derived from mice and alpacas (ide-cel and cilta-cel), Equecabtagene Autoleucel’s unique design reduces immunogenicity while enhancing efficacy. Since its launch in China, it has demonstrated significant therapeutic effects and safety, with a total response rate of 98.9%, a complete response rate of 82.4%, and a one-year progression-free survival rate of 85.5%.

#### Global Recognition: The Significance of IMWG Guidelines

The IMWG guidelines are developed by top global experts in multiple myeloma, providing the latest research findings and best practice recommendations for CAR-T therapy. The “2024 IMWG RRMM CAR-T Guidelines” not only recognize the excellent efficacy of Equecabtagene Autoleucel but also offer detailed guidance on patient selection and safety management, covering the management of unique toxicities such as cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) during treatment.

#### Looking Ahead: Benefiting More Patients

The inclusion of Equecabtagene Autoleucel in the IMWG guidelines showcases China’s leading position in CAR-T therapy development and will help further expand its application globally. This achievement is a significant breakthrough for China’s biopharmaceutical field and brings new treatment hope for RRMM patients worldwide. With ongoing clinical research and real-world data accumulation, Equecabtagene Autoleucel is expected to benefit more patients domestically and internationally, continuously advancing CAR-T therapy.

In the global treatment landscape for multiple myeloma, Equecabtagene Autoleucel is at the forefront, bringing new hope to countless patients. Stay tuned to Equecabtagene Autoleucel and witness the outstanding innovation and global impact of China’s biopharmaceutical industry!

🎉🎉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

#EquecabtageneAutoleucel #CART #MultipleMyeloma #CancerTreatment #Biopharmaceuticals #IMWG2024 #MedicalBreakthrough #InnovativeTherapy #GlobalHealthcare #CancerResearch #PatientHope #ChineseMedicine #Immunotherapy


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4 months ago CAR-T , Leukemia

Chinese Hospital’s CAR-T Therapy Saves the Life of a Ph+ Acute Lymphoblastic Leukemia Patient

### Chinese Hospital’s CAR-T Therapy Saves the Life of a Ph+ Acute Lymphoblastic Leukemia Patient | Successful Case from The First Affiliated Hospital of Chongqing Medical University

CAR-T Therapy

CAR-T Therapy

On November 7, 2023, China’s first CAR-T product for treating adult leukemia, Yuan Ruida (Inaticabtagene Autoleucel Injection), was officially approved for market release. This marks a significant breakthrough in the field of leukemia cellular immunotherapy in China. Recently, The First Affiliated Hospital of Chongqing Medical University successfully treated a young patient with Philadelphia chromosome-positive (Ph+) B-cell acute lymphoblastic leukemia (B-ALL), demonstrating the remarkable efficacy of this innovative therapy.

**Successful Case**

The patient, a 20-year-old female, was diagnosed with Ph+ B-ALL in early 2021. Despite undergoing tyrosine kinase inhibitors (TKI) combined with chemotherapy and hematopoietic stem cell transplantation (HSCT), her disease relapsed multiple times. Finally, she tried CAR-T therapy. On February 23, 2024, the patient received a transfusion of Inaticabtagene Autoleucel Injection. Just one month after the transfusion, she achieved complete remission (CR) and minimal residual disease (MRD) negativity. Currently, the patient is recovering well and is about to return to school.

**Professional Care from the Medical Team**

Throughout the treatment, the expert team at The First Affiliated Hospital of Chongqing Medical University demonstrated exceptional medical skills and meticulous care. Professor Li noted that after multiple treatment failures, the patient chose the innovative therapy of Inaticabtagene Autoleucel Injection, which ultimately yielded gratifying results. During the CAR-T transfusion, the medical team closely monitored the patient’s condition, ensuring the safety and effectiveness of the treatment. The patient’s positive attitude and family support also laid the foundation for successful treatment.

**Support from Commercial Insurance**

This treatment not only relied on advanced medical technology but also benefited from the support of the patient’s family’s commercial insurance. During the treatment, the patient’s family actively applied for commercial insurance claims and successfully obtained full compensation, significantly reducing the financial burden. The support from commercial insurance increased the accessibility of the treatment, providing solid backing for the patient’s recovery.

**Future Prospects**

The approval of Inaticabtagene Autoleucel Injection has brought new hope to B-ALL patients, especially young ones. The excellent efficacy and safety of CAR-T therapy will significantly improve their quality of life. With more successful cases emerging, CAR-T therapy is expected to become the new standard for B-ALL treatment.

The successful case at The First Affiliated Hospital of Chongqing Medical University not only showcases the immense potential of Inaticabtagene Autoleucel Injection in treating leukemia but also provides valuable experience and reference for future clinical applications. The patient’s recovery journey is inspiring, symbolizing not only physical recovery but also a rebirth of the spirit.

**Conclusion**

The successful application of CAR-T therapy has shown leukemia patients a light of recovery. The professional team at The First Affiliated Hospital of Chongqing Medical University will continue to promote this innovative therapy, bringing hope and new life to more patients. With the advancement of medical technology and the support of commercial insurance, the future of patients will be even brighter.

🎉🎉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

#CARTherapy #LeukemiaTreatment #InnovativeMedicine #ChongqingMedicalUniversity #MedicalBreakthrough #NewLife #CommercialInsurance #PatientRecovery #CancerTreatment #MedicalTechnology #PatientStory #MedicalAdvancement #HopeAndHealing #ChineseHealthcare #CARTTreatment #PhALL #HealthyFuture

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