Chongqing Precision Biotech Co., Ltd.'s MC-1-50 cell preparation has received another clinical trial approval by implication from the National Medical Products Administration (NMPA), mainly for the treatment of ≥18 years old patients with relapsed/refractory CD19 positive B-cell acute lymphoblastic leukemia (r/r B-ALL).
The PRIMCAR-based®The MC-1-50 product developed by the platform,Updated clinical data for the r/r B-ALL indication. A total of 19 patients with r/r B-ALL received MC-1-50 treatment, exceedingHalf of the patients had a myeloma burden ≥50% (11/19), and the cell preparation time for all subjects was approximately 2 days. In terms of safety, the majority of patients (18/19, 95%) experienced cytokine release syndrome (CRS) of grade 2 or lower, with one patient (5%) experiencing grade 3 CRS; no cases of CRS grade 4 or higher were observed. Only two patients (11%) developed grade 1 immune effector cell-associated neurotoxicity syndrome (ICANS), and one patient (5%) experienced grade 2 ICANS, with no occurrences of ICANS grade 3 or higher; no dose-limiting toxicity was observed during treatment. Regarding efficacy, the overall response rate (ORR) reached 100%, with more than 50% of patients achieving sustained complete remission (CR) without undergoing transplantation; the main cause of relapse in patients was CD19-negative relapse or CD19 mutation.
At the 2023 ASCO Annual Meeting, Phase I clinical research data on MC-1-50 for the treatment of r/r B-NHL was also disclosed. The study included a total of 13 cases of r/r B-NHL, including DLBCL, CLL, FL, MCL, and HGBL. The cell preparation time for all subjects was approximately 2 days. In terms of safety, CRS occurred in 23% of patients, with 2 patients (15%) experiencing Grade 1 CRS and 1 patient (8%) experiencing Grade 2 CRS; no CRS ≥ Grade 3 was observed. No ICANS were observed in any of the patients, and no dose-limiting toxicity was found during the treatment process. In terms of efficacy, at 5×105All patients in the CAR+/kg dose group achieved CR, and those who achieved CR experienced longer-lasting remission, suggesting greater patient benefit at this dose level.
BaseIn PRIMCAR®The MC-1-50 product of the platform has demonstrated significantly superior treatment data in terms of both efficacy and safety in r/r B-ALL and r/r B-NHL patients, outperforming publicly available CAR-T products targeting the same site that are traditionally manufactured.Product competitiveness.This also shortens the Vein-To-Vein (from blood collection to reinfusion) time for CAR-T products to one week, not only solving the problem of long patient waiting times but also significantly improving production turnover and reducing production costs.(Source:Chongqing Precision Biotech Co., Ltd.
