Bio-gene Announces Promising Phase I Data of GPRC5D-Targeted CAR-T Therapy in Relapsed/Refractory Multiple Myeloma at EHA 2024
Bio-gene
CAR-T Cell Therapy Product Developer
June 1, 2024
eMedClub News
Guangzhou Bio-gene Technology Co., Ltd. ("Bio-gene"), an innovative biotechnology company focused on immune cell therapy, announced that it will present the latest clinical data of its GPRC5D-targeted CAR-T cell product for the treatment of patients with relapsed/refractory multiple myeloma (R/R MM) in a poster presentation at the 29th Annual Meeting of the European Hematology Association (EHA) in 2024.
Abstract
Title
SAFETY AND EFFICACY ANALYSIS OF GPRC5D-TARGETED CAR-T CELL THERAPY IN RELAPSED/REFRACTORY MULTIPLE MYELOMA PATIENTS
Safety and Efficacy Analysis of CAR-T Cell Therapy Targeting GPRC5D in Patients with Relapsed/Refractory Multiple Myeloma
Abstract Number
P965
The data disclosed this time come from a single-center, single-arm, Phase I clinical study (NCT05739188) initiated by investigators from Guangzhou Bio-gene Technology Co., Ltd. and Professor Wang Sanbin's team at the 920th Hospital of the Joint Logistics Support Force of the Chinese People's Liberation Army. The study aims to evaluate the efficacy and safety of autologous GPRC5D CAR-T therapy in patients with R/R MM.
As of April 27, 2024, a total of 10 patients had received a single intravenous infusion of autologous GPRC5D CAR-T cells and underwent clinical evaluation, including 3 casesPreviously received BCMA CAR-T therapypatients. Analysis showed that the median age (range) of the 10 patients was 52 years (45, 68). The median result (range) of minimal residual disease (MRD) in bone marrow before GPRC5D CAR-T infusion was 1.55% (0, 28.22), and the median serum M protein content (range) was 7.8 g/L (0, 63.21). Among them, 8 patients had their GPRC5D antigen expression rate in tumor cells detected by flow cytometry during the screening period, with a median positive expression rate (range) of 50.45% (0, 68.5).
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Safety
No dose-limiting toxicity (DLT) or neurotoxicity was observed. Cytokine release syndrome (CRS) occurred in 90% of patients (n=9/10), all of which were grade 1, and adverse reactions above grade 2 were only hematological toxicity.
Effectiveness
10 cases of patientsOverall Response Rate (ORR) was 90%, Complete Response (CR) or better in 6 cases, Very Good Partial Response (VGPR) and Partial Response (PR) in 3 cases, and No Response (NR) in 1 case. The NR patient had negative GPRC5D expression in tumor cells during the screening period. Notably, among the 6 patients confirmed to have positive GPRC5D expression during the screening period, 5 achieved CR and 1 achieved VGPR. As of the latest follow-up, all 6 patients are still experiencing ongoing responses.
Conclusion
GPRC5D is a promising and safe therapeutic target for MM immunotherapy. CAR-T therapy targeting GPRC5D represents a highly potential treatment option for patients with GPRC5D-positive R/R MM, especially those refractory to BCMA CAR-T therapy.
About Bio-gene
Guangzhou Bio-gene Technology Co., Ltd. is committed to developing world-leading cell therapy drugs for the treatment of hematologic malignancies, including leukemia and lymphoma, as well as various solid tumors. The company has applied for 32 patents on core technologies such as the structural sequence and preparation methods of a new generation of CAR-T cell therapy products, including 7 PCT patents and more than 10 authorized invention patents, establishing a strong intellectual property barrier.
Currently, the autologous CAR-T product for AML has demonstrated excellent efficacy and safety in more than 10 patients involved in multicenter IIT studies, and is undergoing registrational clinical trials; universal cell therapy products based on γδT cells are being evaluated in IIT clinical research.
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