Phase I Clinical Trial Results of PA3-17 Injection, the World’s First IND-Approved Autologous Anti-CD7 CAR-T Therapy, to Be Presented at ASCO 2024
PersonGen
Developer of Tumor Cell Immunotherapy Technologies and Products
Bo Sheng Ji announced today that following the selection of two major products from its internationally leading universal UCAR-Vδ1T platform2024 AACR ConferenceAfterward, the company is about to2024 ASCO ConferenceUpOral ReportAnother heavyweight product, PA3-17 Injection, with Phase I clinical trial dose escalation and dose expansion data.
According to the results of registered clinical trials already obtained,PA3-17 Injection Demonstrates Controllable Safety and Highly Encouraging Efficacy!
American Society of Clinical Oncology Annual Meeting (ASCO Annual Meeting)It is the largest-scale international conference in clinical oncology to date, with the highest academic standards and authoritative level. It gathers oncology experts, doctors, researchers, and pharmaceutical industry representatives from around the world. The ASCO Annual Meeting is an academic feast for researchers in the field each year, where many important research findings and results are disclosed for the first time. The conference shares the latest oncology research achievements, discusses cutting-edge treatment methods and technologies, and promotes scientific progress in the field of oncology.
The ASCO Annual Meeting will be held at the McCormick Place Convention Center in Chicago, USA, from May 31 to June 4, 2024.More than 7,000 articlesSubmission, with only a small portion selected for oral presentation. Oral presentations are an important part of the ASCO Annual Meeting, primarily showcasing the most representative scientific research from different cancer fields that has the greatest impact on oncology research and practice, and are of great significance for patient treatment.Bo Sheng Ji Medicine Science and Technology (Suzhou) Co., LTD is honored to be selected asOral ReportReport on the Registration Clinical Phase I of the Heavyweight Product PA3-17 InjectionClimbingAnd dose expansion data.
PA3-17 Injection isThe World's FirstThe autologous CD7-CAR-T product approved for IND has its registration clinical trial led by Academician Huang Xiaojun from Peking University People's Hospital and Director Zhang Mingzhi from the First Affiliated Hospital of Zhengzhou University. Director Mei Heng from Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, and Director Zou Dehui from the Hematology Hospital of the Chinese Academy of Medical Sciences are also participating.
Oral Report
Dr. HuiMin Meng, Senior Medical Director of Bo sheng ji medicine science and technology (suzhou) co., LTD, said:
T-Lymphoblastic Leukemia/Lymphoma (T-ALL/LBL) is a highly aggressive malignant hematological tumor. Chemotherapy is the primary clinical treatment for T-ALL/LBL. Although the complete remission rate after induction chemotherapy exceeds 90%, about 40% of patients will experience disease relapse. The prognosis for previously relapsed/refractory T-ALL/LBL patients has been very poor, with a long-term survival rate of less than 10%. Despite the continuous increase in treatment options in recent years, the five-year survival rate for relapsed/refractory T-ALL/LBL patients remains below 20%. The Phase I clinical data that we are about to present orally at the 2024 ASCO conference shows that, as the world's first autologous CD7-CAR-T product approved for IND, it will bring more benefits to the patient population with relapsed/refractory T-ALL/LBL. We will continue to advance the full clinical development of PA3-17 injection and look forward to achieving the goal of launching the world’s first autologous CD7-CAR-T cell drug.
Efficacy of PA3-17 Injection
As of November 28, 2023, a total of 12 patients (3 patients in each of the 3 dose groups, and 3 patients in the RP2D group) were enrolled. All patients received a single infusion of PA3-17 injection and completed the 28-day DLTs evaluation. The median age of the patients was 33.5 years (range 20-64 years), and 25.0% (3/12) of the patients had previously undergone allogeneic hematopoietic stem cell transplantation. The RP2D was 2×10.6CAR-T/kg. Efficacy data show:
■The best objective response rate (ORR) was 83.3% (10/12);
■The complete remission (CR) rate was 75% (9/12);
■The median follow-up time was 213.5 days, with 2 patients maintaining CR status for 9 months and still in ongoing remission;
■One patient had a tumor diameter greater than 7cm at baseline, but reached CR 28 days after the infusion of PA3-17 injection.
Safety of PA3-17 Injection
Through the 28-day DLTs evaluation, PA3-17 injection demonstrated controllable safety, with no DLTs occurring in any of the dose groups.
■83.3% (10/12) of patients experienced cytokine release syndrome (CRS), with 58.3% (7/12) being grade 1-2, 25% (3/12) being grade 3, and no occurrence of grade 4 CRS;
■16.7% (2/12) of patients developed grade 1-2 immune effector cell-associated neurotoxicity syndrome (ICANS);
■No ICANS of grade 3 or higher occurred.
PA3-17 Injection Shows Promise in Relapsed/Refractory T-ALL/LBL PatientsGood safety and encouraging efficacy, will continue to collect long-term safety and efficacy data, and the pivotal confirmatory Phase II clinical study is about to begin.
