Two Years of Complete Remission(Lymphoma), CAR-T therapy has given her a new lease on life.

“Two Years of Complete Remission, CAR-T therapy has given her a new lease on life.  She Thought the Journey Was Over”

Yun is a 78-year-old patient who achieved a continuous complete remission for two and a half years despite relapsed/refractory diffuse large B-cell lymphoma. Diagnosed in 2019, after enduring six rounds of chemotherapy, she initially achieved complete remission as confirmed by her healthcare team. Unfortunately, the period of remission was short-lived as Yun soon experienced disease relapse, and subsequent second-line treatments failed to yield positive results.

“I vividly remember when Director Wang Li encouraged me, mentioning an advanced method called Car-T, but it was quite expensive. I was hesitant, but I discussed it with my son when I got home. When my son and daughter-in-law heard about it, they insisted on treatment. My son said, ‘Mom, you’re the only mother I have in this world. As long as you’re here, our home is complete. Money can be earned again, and if the treatment isn’t successful, at least we won’t have regrets.’ I was deeply moved. At my age, I’ve already shown strength through previous treatments. I believe that wherever my health takes me is where I belong. Everyone’s support gave me a reason to stay strong again.”

In 2021, CAR-T cell therapy was approved and launched in China, and Yun underwent this treatment at Ruijin Hospital.

Dr. Wang Li, Director of Hematology at Ruijin Hospital, explained, “CAR-T cell therapy provides new treatment options for a wide range of cancer patients.”

“Before planning Yun’s CAR-T cell therapy, lymphoma experts, considering her current tumor status and medical history, anticipated potential adverse reactions during the treatment process and discussed handling protocols. Yun’s entire journey with CAR-T cell therapy was challenging. The medical team meticulously coordinated their efforts, successfully addressing adverse reactions after CAR-T treatment, ultimately averting potential risks.”

Despite lying in her hospital bed, Yun deeply appreciates the relentless dedication of her medical caregivers. “Sometimes, directors come to see me after 10 p.m., telling me they worked late but had to check on me; some arrive by my bedside as early as 7 a.m., concerned about my well-being. I continuously remind myself that I must strive, persist, and live up to the efforts made by doctors and my entire family,” said the 78-year-old Yun . “I made it through.”

#CARTCellSuccess #CancerWarrior #CompleteRemissionChronicles  #FamilySupportMatters #CAR-TBreakthrough #InspiringHealthJourney #MedicalMiracles #NeverTooLateToFight #Cancerfight #Bloodcancer

#lymphoma

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10 months ago CAR-T

New Generation CAR-T Cell Therapy AT101: Phase I Clinical Trial Shows 100% Complete Remission Rate!

New Generation CAR-T Cell Therapy AT101: Phase I Clinical Trial Shows 100% Complete Remission Rate!

Researchers recently released exciting news: the Phase I clinical trial of their newly developed CAR-T cell therapy, AT101, demonstrated a 100% complete remission rate among patients receiving high-dose treatment. This groundbreaking achievement was published in the latest “Molecular Cancer” journal and gained significant attention at the 65th American Society of Hematology (ASH) Annual Meeting.

 

Despite recent FDA investigations into the safety of CAR-T cell therapy, it remains the most promising choice for blood cancer patients who have tried other treatment methods unsuccessfully. CAR-T cell therapy has fundamentally changed the treatment landscape for many blood cancer patients. While some patients show long-term responses to it, others do not.

 

The new CAR-T cell therapy, AT101, developed by researchers from the Perelman School of Medicine and the Abramson Cancer Center at the University of Pennsylvania, exhibited highly encouraging results due to its design targeting a new epitope of CD19 through a unique binding mechanism. Most currently approved CD19 CAR-T cell therapies target the same epitope, yet many patients eventually relapse. AT101, by targeting a different CD19 epitope, shows faster action rates and aims to reduce the failure rate of CAR-T cell therapy while improving clinical efficacy.

 

In this Phase I clinical trial, 14 patients with relapsed or refractory B-cell non-Hodgkin lymphoma (NHL) received treatment. Nine out of twelve patients achieved a complete remission status, indicating a total remission rate of 91.7%, with eight patients achieving complete remission. These patients did not experience cancer relapse, and the drug showed promising safety results.

 

While further research and larger-scale clinical trials are necessary, these early results instill considerable confidence. The success of AT101 holds promise for bringing new hope to blood cancer patients, especially those who previously did not receive effective CAR-T cell therapy. This study also aims to expand to a broader patient population, offering more treatment options and possibilities.

 

#CARTTherapy #BloodCancerTreatment #AT101Research #CancerRemission #MedicalBreakthrough #ASHAnnualMeeting #ClinicalTrialSuccess #UniversityResearch #CancerResearchUpdate #HopeForPatients #AT101 #BloodCancer #CancerTreatment

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10 months ago CAR-T

Breakthrough in CAR-T Therapy Achieved by Chinese Sun Yat-sen University Cancer Center

Recently, Professor Huang Huiqiang’s team at Sun Yat-sen University Affiliated Cancer Hospital achieved significant progress in a lymphoma patient who relapsed after five lines of chemotherapy. Utilizing CAR-T therapy, the patient has experienced complete remission for over two years, making them one of the patients in China with the longest survival post-CAR-T treatment.

Lymphoma, one of the common blood cancers, has traditionally been treated using a combination of chemotherapy, autologous hematopoietic stem cell transplantation, targeted therapies, and immune-modulating drugs. However, CAR-T cell therapy, an advanced technology in the field of oncology, has emerged as a precise, rapid, and highly effective new treatment method in recent years.

 

Diffuse large B-cell lymphoma is a prevalent aggressive lymphoma characterized by rapid progression, high mortality rates, and short survival periods. Despite significant therapeutic advancements in recent years, approximately 70% of patients achieve good outcomes and long-term remission through first-line treatments, but around 30% of patients have inadequate responses to treatment, facing difficult-to-cure relapses.

Professor Huang Huiqiang emphasized, “CAR-T cell therapy plays a crucial role in providing new treatment hopes for relapsed and refractory patients who cannot undergo transplantation or have previously undergone ineffective treatments.

It is reported that in the future, Sun Yat-sen University Cancer Center will continue to explore clinical innovative technologies in CAR-T cell therapy, aiming to bring new prospects for numerous patients.

 

 

#CARTBreakthrough #CancerResearch #SunYatSenCancerCenter #InnovativeTherapies #MedicalBreakthrough #LymphomaTreatment #PrecisionMedicine #HopeForPatients #CancerSurvivorship #AdvancedOncology #MedicalInnovation #ResearchProgress #ScienceNews #HealthcareAdvancements #ImmunotherapySuccess #Cancer

 

10 months ago CAR-T

Global First: Chinese CAR-T Therapy Simultaneously Cures Tumor and Lupus Erythematosus

China make advanced medical treatment affordable

Wang Fang (pseudonym), residing in Yichang, Hubei, China, underwent a life-threatening ordeal. This patient in her forties had been suffering from systemic lupus erythematosus for over 20 years. What exacerbated her agony was the excruciating pain in her right leg since June 2019, which forced her into a wheelchair. Local hospital diagnosis revealed an aggressively invasive tumor—diffuse large B-cell lymphoma.

 

In mid-August 2019, Wang Fang followed a relative’s advice and sought treatment at Peking University Shenzhen Hospital (hereinafter referred to as “PKU Shenzhen Hospital”) in Shenzhen, where she was fortunate to participate in clinical trials for blood tumors. In mid-September 2019, she underwent the compound dual-target CAR-T (CD19/BCMA) cell immunotherapy.

 

Miraculous changes occurred a month after treatment; her lymphoma vanished entirely. Two months later, she was freed from the wheelchair and could walk independently. The nine-month follow-up, more astonishingly, revealed not only the complete disappearance of lymphoma but also the reversal of her long-standing stubborn lupus erythematosus antibodies, signifying her clinical cure from lupus.

 

This is the first documented instance globally where compound dual-target CAR-T cell immunotherapy cured diffuse large B-cell lymphoma and refractory lupus erythematosus—a significant breakthrough in Shenzhen’s oncology clinical research and treatment field.

 

This patient, originally from another region, had relied on steroids and other drugs to manage her condition for over 20 years due to systemic lupus erythematosus. However, the intensified pain in her right leg in June 2019 led to the diagnosis of an invasive tumor, rapidly deteriorating her condition and confining her to a wheelchair.

 

When faced with chemotherapy recommendations at the local hospital, Wang Fang declined due to the side effects she had previously experienced. Fortunately, a relative’s recommendation brought her to PKU Shenzhen Hospital. With the doctors’ dedicated assistance, Wang Fang participated in the clinical trial of CAR-T cell immunotherapy.

 

CAR-T cell therapy is an advanced treatment method that transforms a patient’s own T cells into CAR-T cells capable of identifying and attacking tumor cells. Since its successful treatment of the first case of acute lymphoblastic leukemia in the United States in 2012, this treatment has gradually become a groundbreaking technology in the field of tumor therapy. The Blood Department of PKU Shenzhen Hospital, as a pioneer, has completed over 30 cases of CAR-T cell therapy clinical trials, offering hope for those patients in critical conditions with ineffective traditional treatments.

 

Considering the uniqueness of Wang Fang’s disease, the team designed a compound dual-target CAR-T cell immunotherapy targeting both CD19 and BCMA. The success of this advanced therapy made Wang Fang the first case globally to be cured of lupus erythematosus using CAR-T cell therapy.

 

One month after treatment, she no longer needed wheelchair assistance; two months later, she could walk independently; and nine months later, besides the complete eradication of the tumor, the lupus erythematosus-related antibodies turned negative, leading to her clinical cure without relying on medication for her daily life.

 

Director Zhang Hongyu from the Blood Department of PKU Shenzhen Hospital stated that this successful case marks a significant breakthrough in CAR-T cell therapy, offering the possibility of cure to more patients. This successful clinical trial was also reported at the 61st American Society of Hematology (ASH) Annual Meeting, highlighting PKU Shenzhen Hospital’s significant contributions to the medical field.

 

After enduring this arduous battle, Wang Fang has regained her health and freedom. She expresses gratitude for the exceptional skills and selfless assistance of the medical team at PKU Shenzhen Hospital. Currently, for nine months, she has not taken any medication, regaining her beautiful hair and radiating vitality, looking forward to the future.

 

The appearance of this successful case brings hope and inspiration to the global medical community, showcasing the potential of CAR-T cell therapy in continuous exploration. The Blood Department team at PKU Shenzhen Hospital intends to continue exploring more effective and safer treatment approaches, bringing more hope for patients.

 

10 months ago CAR-T

The latest research findings of BCMA CAR-T therapy for multiple myeloma in 2023 | Equecabtagene Autoleucel (FUCASO)

The latest research findings of BCMA CAR-T therapy for multiple myeloma in 2023 | Equecabtagene Autoleucel (FUCASO®)

    IASO Bio and Innovent presented their latest research findings on the Equecabtagene Autoleucel injection (brand name: FUCASO®) for multiple myeloma at the 2023 American Society of Hematology (ASH) Annual Meeting. This study was primarily based on a post-hoc analysis of the FUMANBA-1 study, an Ib/II phase research assessing the efficacy and safety of this therapy in treating patients with relapsed and refractory multiple myeloma (RRMM).

    As of December 31, 2022, with a median follow-up of 18.07 months, deep and sustained responses were observed in 103 evaluable patients. Among these patients, the overall response rate (ORR) was 96.1%, and the stringent complete response/complete response (sCR/CR) rate was 77.7%. Among subjects without prior CAR-T therapy, the ORR reached 98.9%, the sCR/CR rate reached 82.4%, and the 12-month progression-free survival (PFS) rate was 85.5%.

Minimal residual disease (MRD) negativity rate is 94.2% in the total evaluable patients, and all patients who achieved CR or above were MRD negative. The median time to achieve MRD negativity was 15 days, with 80.8% of patients remaining MRD negative at 12 months post infusion.

In addition, Equecabtagene Autoleucel could persist in the body for an extended period of time the median duration was 307.5 days. 12 months after infusion, 50% of patients had a vector copy number (VCN) above the lower limit of detection; and 24 months after infusion, VCN could still be detected in 40% of the patients.

The research findings indicate a strong correlation between sustained MRD negativity and patient progression-free survival (PFS), along with the continuous presence of Equecabtagene Autoleucel in the body, which correlates positively with sustained MRD negativity.

The Equecabtagene Autoleucel injection may improve the long-term survival prospects of RRMM patients, offering enduring deep remission and holding significant importance for the sustained maintenance of MRD negativity in patients.

About Multiple Myeloma (MM)

Multiple Myeloma is a deadly blood cancer that often infiltrates the bone marrow causing anemia, kidney failure, immune problems, and bone fractures. For multiple myeloma patients, common first-line drug treatments include proteasome inhibitors, immunomodulatory drugs, and alkylating agents. While treatment may result in remission, most patients will inevitably enter the relapsed or refractory stage as there’s currently no cure. As a result, there is a significant unmet need for patients with relapsed/refractory multiple myeloma. In the United States, MM accounts for nearly 2% of all cancer cases, and more than 2% of cancer-related deaths.

According to Frost & Sullivan, the number of new MM cases in the United States rose from 30,300 in 2016 to 32,300 in 2020 and is expected to increase to 37,800 by 2025. Additionally, the total number of patients diagnosed with MM increased from 132,200 in 2016 to 144,900 in 2020 and is expected to rise to 162,300 by 2025. In China, the number of new MM cases rose from 18,900 in 2016 to 21,100 in 2020 and is expected to increase to 24,500 by 2025. The total number of patients diagnosed with MM in China increased from 69,800 in 2016 to 113,800 in 2020 and is expected to rise to 182,200 by 2025.

About Equecabtagene Autoleucel

Equecabtagene Autoleucel is an innovative fully-human anti-BCMA CAR-T cell therapy that uses lentivirus as a gene vector to transfect autologous T cells. The CAR comprises a fully-human scFv, CD8a hinge and transmembrane, as well as 4-1BB-mediated co-stimulation and CD3ζ activation domains. Through rigorous screening and comprehensive in vivo and in vitro evaluation, Equecabtagene Autoleucel has been proven to possess potent and rapid anti-myeloma activity, along with outstanding safety, efficacy, and persistence results.

Equecabtagene Autoleucel has received acceptance for New Drug Application (NDA) from China’s National Medical Products Administration (NMPA) for the treatment of RRMM and has obtained IND approval from the U.S. FDA. Additionally, the company was granted Breakthrough Therapy Designation (BTD) by the NMPA in February 2021, Orphan Drug Designation (ODD) in February 2022, and Regenerative Medicine Advanced Therapy (RMAT) and Fast Track (FT) Designations from the FDA in February 2023. Besides multiple myeloma, NMPA has accepted its IND application for the new extended indication of Neuromyelitis Optica Spectrum Disorder (NMOSD). Innovent and IASO Bio are collaboratively developing Equecabtagene Autoleucel for the treatment of RRMM in mainland China.

About IASO Biotechnology

IASO Bio is a clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and autoimmune diseases. Leveraging its proprietary fully human antibody discovery platform (IMARS), high-throughput chimeric antigen receptor T-cell (CAR-T) drug screening platform, and proprietary manufacturing processes, IASO Bio is developing a robust clinical-stage pipeline of multiple autologous and allogeneic CAR-T and biologics product candidates. This pipeline comprises a diversified portfolio of over 10 novel products, including IASO’s flagship asset, Equecabtagene Autoleucel (CT103A), a fully human BCMA CAR-T injection.

In addition to Equecabtagene Autoleucel, the company’s pipeline includes the fully developed in-house human CD19/CD22 dual-targeted CAR-T cell therapy, which has received two IND clearances for treating relapsed/refractory B-cell non-Hodgkin’s lymphoma (r/r B-NHL) and relapsed/refractory acute B-lymphoblastic leukemia (r/r B-ALL). CD19/CD22 is currently in Phase I clinical trials for r/r B-NHL. It was also granted ODD by the FDA in October 2021. In the approximately 20 patients dosed to date in the investigator-initiated trial, there were no immune effector cell-associated neurotoxicity syndrome (ICANS) observed in any patient, and the rate of grade 3 cytokine release syndrome (CRS) was less than 5%, with the remainder of patients experiencing no CRS or less than grade 3.

Leveraging its strong management team, innovative product pipeline, integrated manufacturing, and clinical capabilities, IASO aims to deliver transformative, curable, and affordable therapies that fulfill unmet medical needs to patients in China and around the world.

#BCMACART #EquecabtageneAutoleucel #FUCASO #ASH2023 #ClinicalResearch #Hematology #CARTtherapy #MRDnegative #CancerTreatment #MedicalInnovation #BloodCancer #OncologyResearch #DrugApproval #CellTherapy #CancerSurvival #FDAapproval #NMPAapproval #Biopharmaceutical #ClinicalTrials #MM

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