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Tags Archives: ClinicalTrials


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9 months ago CAR-T

Clinical Breakthrough: Chinese CAR-T – Inaticabtagene Autoleucel Revolutionizing Hematologic Cancer Therapy

“Clinical Breakthrough: Chinese CAR-T – Inaticabtagene Autoleucel Revolutionizing Hematologic Cancer Therapy”
On January 5, 2024, the Fourth Chinese Hematology Development Conference was convened in Tianjin, China, concurrently hosting the CAR-T Frontier Forum and the First CAR-T Cell Immunotherapy Summit (JCIS). The focus was directed towards the latest advancements and clinical applications of Inaticabtagene Autoleucel, presenting new pathways for standardized treatments.
 
Under the moderation of Professors Wu Depei and Hu Yu, Professor Wang Ying from the Institute of Hematology at the Chinese Academy of Medical Sciences presented a specialized lecture titled “Interpreting Key Clinical Data of Inaticabtagene Autoleucel.” Professor Wang highlighted the challenges faced by adult B-ALL patients in China, commonly treated with salvage chemotherapy ± hematopoietic stem cell transplantation. However, the median survival period is only 2-6 months, and targeted therapies yield a median survival of merely 7.7 months, necessitating an urgent need for more effective treatment methods. Recently, the Inaticabtagene Autoleucel infusion has been approved for treating adult R/R B-ALL patients.
 
Critical clinical research (NCT04684147) has revealed the substantial outcomes achieved with a single treatment of Inaticabtagene Autoleucel:
 
Rapid and profound remission: Within 3 months of treatment, the overall response rate (ORR) reached an impressive 82.1%, with a 100% negativity rate for minimal residual disease (MRD), showcasing the remarkable effects of Inaticabtagene Autoleucel within a short span.
 
Enduring remission: The 3-month post-treatment overall remission rate stood at 64.1%, with a 12-month sustained remission rate (DOR) of 80%. With a median follow-up of 8.0 months, the median relapse-free survival (RFS) period has not been reached. The one-year survival rates for overall infused patients, those achieving complete response (CR)/complete response with incomplete hematological recovery (CRi) within 3 months, and those reaching CR/CRi at 3 months were 67.9%, 72.0%, and 85.6%, respectively.
 
Good safety profile: The incidence rate of ≥3-grade cytokine release syndrome (CRS) was only 10.3%, and that of ≥3-grade immune effector cell-associated neurotoxicity syndrome (ICANS) was merely 7.7%. Moreover, patients recovered post-treatment without complications.
 
Furthermore, data from over 100 patients validated the clinical efficacy and safety of Inaticabtagene Autoleucel, affirming its robustness and offering renewed hope to a larger patient population. This breakthrough treatment provides a new avenue for tackling challenging diseases and is poised to revolutionize the landscape of hematologic cancer therapy.
 
#CARTRevolution #InaticabtageneAutoleucel #HematologicCancerTherapy #ClinicalBreakthrough #ChinaHematologyConference #JCIS #BAllTreatment #MedicalAdvancements #CancerResearch #TreatmentInnovation #InaticabtageneAutoleucel #Autoleucel #ChineseCART #CARTTherapy #cancer #Bloodcancer #MedicineinCHINA #Medicaltourismo #Advancedmedicine #cancertherapy


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10 months ago CAR-T

Breakthrough Advances in CAR-T Cell Therapy Combined with TKI for Malignant Hematologic System Tumors

Breakthrough Advances in CAR-T Cell Therapy Combined with TKI for Malignant Hematologic System Tumors
At this year’s ASH conference, Professor Huang He, the director of the First Affiliated Hospital of Zhejiang University School of Medicine, presented a significant study on CAR-T cell therapy for B-ALL, marking a groundbreaking stride in the treatment of malignant hematologic system tumors.
 
This study, targeting newly diagnosed adult Ph-positive acute lymphoblastic leukemia, investigated the combined treatment of dasatinib and CAR-T cell therapy as a frontline therapy for initial patients. The integration of CAR-T cell therapy with tyrosine kinase inhibitors (TKI) aimed to enhance treatment effectiveness.
 
The study revealed promising outcomes: among 18 patients, the complete molecular remission rate after CD19 CAR-T cell therapy reached 72.2%. Among these patients, subsequent treatment with CD22 CAR-T cells achieved a complete molecular remission rate of 76.9%. At a median follow-up of 13.5 months post CAR-T cell therapy, 16 patients maintained complete hematological remission, while 14 patients sustained complete molecular remission without undergoing allogeneic transplantation. Notably, no CRS (cytokine release syndrome) ≥ Grade 3 or ICANS (immune effector cell-associated neurotoxicity syndrome) occurred during CAR-T cell therapy.
Professor Huang He’s team’s groundbreaking research presented at the ASH conference signifies a leap forward in the treatment of blood-related cancers, signaling a more efficient and accessible era. These findings instill hope for refining treatment strategies and potentially making a significant impact in the field of hematologic oncology.
Beyond the groundbreaking progress in CAR-T cell therapy combined with TKI, the team showcased seven oral presentations and 26 poster exhibitions. These studies encompassed fundamental research on blood disorders, leukemia pathogenesis, acute lymphoblastic leukemia, acute myeloid leukemia, lymphoma, myeloma, hematopoietic stem cell transplantation, and cellular immunotherapy, all crucial for enhancing clinical practices.
 
We eagerly anticipate further groundbreaking strides by Chinese research teams in cancer treatment studies, anticipating the transformative impact of these research findings in the future.
 
 
#ASHAnnualMeeting #HematologyResearch #CARTCellTherapy #StemCellTransplantation #BloodCancer #ClinicalInnovation #OncologyAdvancements #Cancertherapy #MedicalResearch #ASH #CART #CARTTherapy #CARTCell #TKI #tyrosinekinaseinhibitors

10 months ago CAR-T

Unveiling Hope: Chinese CAR-T Cell Therapy Illuminating New Paths in Liver Cancer Treatment!

2020, over 19.3 million people were diagnosed with cancer worldwide, leading to almost 10 million fatalities. In China alone, the number of new cancer patients reached a staggering 4.57 million, accounting for 23.7% globally. Liver cancer, among the most prevalent malignant tumors in China, witnessed 410,000 new cases and 380,000 deaths, making up 45.3% and 47.1% of the global total, respectively [1]. However, since the 21st century began, significant strides have been made in liver cancer treatments, particularly in medication and localized therapies. Surgical procedures are no longer the sole option for long-term survival among liver cancer patients.

Immunotherapy has emerged as one of the most promising techniques for treating liver cancer, especially with advancements in tumor molecular biology. In 2013, “Science” magazine categorized immunotherapy as the fourth major cancer treatment, following surgery, chemotherapy, and radiation therapy, with cell therapy becoming a focal point of basic and clinical research in recent years.

In May 2020, Professor Zhai Bo’s team from Shanghai Jiao Tong University School of Medicine’s Renji Hospital, in collaboration with Shanghai Sci-Tech Biotechnology’s team led by Li Zonghai, published groundbreaking preliminary clinical research data on CAR-T cell therapy targeting the GPC3 gene for hepatocellular carcinoma in the “Clinical Cancer Research” journal. This breakthrough study brought unprecedented hope for CAR-T cell therapy in liver cancer treatment.

Even more inspiring, their publication in the “Cancer Communications” journal showcased follow-up results of two late-stage liver cancer patients who achieved long-term tumor-free survival after receiving CAR-T cell combined with local therapy [2]. These findings shed new light on the treatment prospects for liver cancer patients.

However, despite the potential therapeutic effects of liver cancer CAR-T cell therapy, it faces challenges and obstacles. Liver cancer’s heterogeneity, tumor microenvironment, and the safety of cell therapy remain crucial issues to address.

Presently, revolutionary changes are underway in the treatment models and concepts for liver cancer. However, integrating CAR-T cell therapy into actual liver cancer treatment requires further scientific exploration and clinical research. Researchers emphasize that only through comprehensive utilization of CAR-T cells in conjunction with other treatment modalities can its therapeutic potential be fully realized.

Professor Zhai Bo’s team is currently conducting various fundamental and clinical studies aimed at exploring additional possibilities for CAR-T cell therapy in solid tumors. These studies include phase I clinical research on EpCAM CAR-T cell combined with ablative therapy for gastrointestinal tumors, phase II clinical research on Claudin18.2 CAR-T cell therapy for gastrointestinal tumors, studies on the mechanism and prevention of OTOT toxicity, among others. These endeavors will provide more experimental data and support for the application of CAR-T cells in the treatment of solid tumors.

In conclusion, liver cancer CAR-T cell therapy signifies a significant breakthrough in the field of liver cancer treatment, offering new hope for patients. Despite the challenges to overcome, the outlook for this therapy is promising and holds the potential to bring a blessing to more patients in the future.

[References]

Zhaibo, Lizonghai etc.

“Chimeric Antigen Receptor-Glypican-3 T-Cell Therapy for Advanced Hepatocellular Carcinoma: Results of Phase 1 Trials.” 《Clinical Cancer Research》, 2020.

“Combined local therapy and CAR-GPC3 T-cell therapy in advanced hepatocellular carcinoma: a proof-of-concept treatment strategy.” 《Cancer Communications》, 2023.

 

#HealthTech#CancerResearch #Immunotherapy #CARTcell #LiverCancer #MedicalBreakthrough #ClinicalTrials #ScienceNews #HealthcareInnovation #ResearchBreakthrough #MedicalScience #CancerTherapy #CancerAwareness #InnovativeMedicine #ImmunotherapyTreatment #ScienceUpdates #HealthcareTechnology #BiomedicalResearch #ClinicalInnovation #CancerTreatment #MedicalAdvancements #ImmunologyResearch #HealthcareIndustry #ProfessionalHealthcare

10 months ago CAR-T , Leukemia

The new hope for pediatric patients with relapsed/refractory B-cell acute lymphoblastic leukemia (R/R B-ALL) boasts an overall survival rate of up to 96%.

The new hope for pediatric patients with relapsed/refractory B-cell acute lymphoblastic leukemia (R/R B-ALL) boasts an overall survival rate of up to 96%.
    Recently, CAR-T cell therapy targeting B-cell malignancies has encountered a series of inquiries and challenges, particularly concerning discussions on CAR-T cell-related toxicity, resistance, antigen escape, and limitations in persistence. However, a groundbreaking concept addressing relapse in patients after CAR-T cell therapy has been introduced for the first time: a sequential approach involving distinct targeted CAR-T cell therapies.
    Within this approach, CD19 CAR-T cell therapy has demonstrated the ability to achieve complete remission in 60% to 90% of relapsed or refractory acute B-cell lymphoblastic leukemia patients. By experimenting with different combinations and sequential administration strategies of B-cell antigen-targeted CAR-T cell therapies, there’s potential to prevent tumor antigen escape and prolong the persistence of CAR-T cells.
    Preliminary clinical trials have provided initial support for this concept, notably a phase II clinical trial aimed at assessing the efficacy of sequential CD19 and CD22 CAR-T cell therapy. Its findings revealed a 79% event-free survival rate, an 80% sustained remission rate, and an impressive 96% overall survival rate among patients receiving targeted doses in sequential therapy. Encouragingly, the overall safety of this sequential therapy appeared manageable, providing long-term survival benefits for children with relapsed or refractory acute B-cell lymphoblastic leukemia.
However, the limitations of antigen escape and limited persistence after CAR-T cell therapy persist. Addressing these challenges, researchers have proposed the hypothesis of sequential administration of CAR-T cell products targeting different antigens, aiming to maintain the persistence of CAR-T cells.
    The results of this phase II clinical trial indicate that administering CD22 CAR-T cell therapy following CD19 CAR-T cell infusion can result in longer-lasting remission effects for pediatric patients with relapsed or refractory B-cell acute lymphoblastic leukemia, achieving an 80% sustained remission rate over 18 months and an impressive 96% overall survival rate. Importantly, the overall safety of this sequential therapy is uplifting, providing long-term survival benefits for this specific patient population.
    In summary, this study presents groundbreaking evidence for new strategies and directions in CAR-T cell therapy. Despite existing limitations, this therapy demonstrates significant potential in treating uncontrollable acute B-cell lymphoblastic leukemia, potentially offering more enduring treatment effects and long-term survival benefits for these patients. This achievement points towards a viable path for the future development of cell therapies.
    This Phase 2 trial, conducted at Beijing GoBroad Boren Hospital in China, enrolled pediatric patients aged 1–18 years diagnosed with relapsed or refractory B-cell acute lymphocytic leukaemia (ALL) showing CD19 and CD22 positivity exceeding 95%.

10 months ago CAR-T , Leukemia

If a child unfortunately gets leukemia, should CAR-T Therapy be considered?

In recent years, CAR-T therapy has gained traction in treating leukemia. A quick search yields numerous articles, many of which describe the miraculous effects of CAR-T.
Is the efficacy of CAR-T therapy really that impressive? Should CAR-T therapy be considered for a child diagnosed with leukemia? Today, let’s unravel these doubts together!
What kind of leukemia patients can undergo CAR-T therapy?
Since most acute leukemia patients are sensitive to chemotherapy, chemotherapy is the preferred initial treatment. Currently, CAR-T therapy is primarily used for refractory and relapsed acute B-cell lymphoblastic leukemia patients.
For cases where 1-2 courses of chemotherapy fail to achieve complete remission (primary refractory), or relapse during chemotherapy, or experience ineffective re-treatment after relapse and re-chemotherapy (refractory relapse), CAR-T therapy is the preferred approach.
Celebrating a decade of being cancer-free for the world’s first leukemia child treated with CAR-T therapy
The world’s first leukemia child cured by CAR-T therapy celebrates 11 cancer-free years
On May 10th each year, Emily Whitehead commemorates the anniversary of her cancer-free survival. This year, she turns 18 and has officially become a nurse, leading a busy and joyful life. With the achievement of this significant milestone, the revolutionary cancer treatment known as CAR-T cell immunotherapy has been officially recognized! She has also become the spokesperson for this epic therapy.
Which CAR-T products are currently on the market?
Since 2017, the approval of the world’s first CAR-T products, Novartis’s Kymriah, and Kite Pharma’s Yescarta by the FDA, has heralded a new era in cell immunotherapy. Presently, there are 10 CAR-T drugs approved for market globally. Additionally, there are over 1,000 CAR-T clinical trials registered worldwide on Clinicaltrials, with nearly 500 projects in mainland China. The primary treatment areas include hematologic malignancies, along with solid tumors such as pancreatic cancer, liver cancer, lung cancer, breast cancer, and colorectal cancer.
More and more people are choosing to seek medical treatment in China. China’s technology in oncology, especially in CAR-T, is now on par with that of the United States. The fundamental reasons why many individuals with related diseases choose China are the high-quality services, pleasant environment, and comparatively affordable prices.
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