Arcellx Announces Global First BCMA/GPRC5D Bispecific CAR-T Therapy YK-CAR-069 with Promising Phase 1 Data in Relapsed/Refractory Multiple Myeloma
Yake Biotechlogy
Developer of Tumor Cell Immunotherapy Technology R&D
On July 24, YAKE BIOTECH announced its independently developed BCMA/GPRC5D bispecific CAR-T cell therapy technology (YK-BCMA-GPRC5D BoomTM, YK-CAR-069）in the internationally renowned journal *The Lancet Haematology*（Impact Factor: 15.4) Published the Phase I Clinical Trial Results. This study was led by the medical team of the Hematology Research Institute of Xuzhou Medical University.
This clinical trial, for the first time, utilized internationally leading BCMA/GPRC5D bispecific CAR-T cell therapy technology, successfully treating 21 cases of relapsed or refractory multiple myeloma (R/R MM) patients, and obtain the overall response rate (ORR) 86% excellent efficacy. Upon reinfusion of the optimal dose, in2 x 106/kgAmong the 12 patients, the ORR was 91.7%, with CR/sCR reaching 75% and VGPR at 16.7%.
Notably, in this clinical trial, all 4 BCMA-negative patients achieved a response and MRD negativity, including 2 patients (50%) achieved sCR; among 6 GPRC5D-negative patients, 5 (83%)Patients achieved a response and MRD negativity, among whom 4 patients (67%) Achieved sCR.
At the same time, this clinical trial also demonstrated the safety of BCMA/GPRC5D bispecific CAR-T cell therapy. Among 21 patients, cytokine release syndrome (CRS) The incidence rate was 71%, all of which were grade 1 or 2 CRS; only one case received the maximum tolerated dose.4 x 106/kg Grade 1 ICANS occurred in the patient, and no ICANS or cytotoxicity above grade 3 was observed in patients receiving doses below the maximum tolerated dose.
BCMA/GPRC5D Bispecific CAR-T Cell Therapy Shows Good Safety and Encouraging Efficacy in Patients with Relapsed or Refractory Multiple Myeloma, Offering Hope for a Cure to Those Who Have Experienced CAR-T Cell Therapy Failure Due to BCMA or GPRC5D Antigen Heterogeneity.
