BCMA/CD19 dual-targeting FasTCAR-T GC012F data from ongoing clinical trial presented at 64th
GC012F is an autologous CAR-T therapeutic candidate dual-targeting B cell maturation antigen (BCMA) and CD19, and utilizes Gracell's proprietary FasTCAR next-day manufacturing platform.
As of the
- ORR was 100%
- 87.5% (14/16) of patients achieved stringent complete response (sCR). Patients continue to be followed for deepening responses
- 100% of evaluable patients achieved MRD negativity in all dose levels
- 100% of evaluable patients achieved MRD negativity at months 1, 6 and 12
- 100% of patients experienced robust CAR-T cell expansion with long persistence in all dose levels
The clinical data also demonstrated an excellent safety profile:
- Only 25% (4/16) of patients experienced Grade 1-2 cytokine release syndrome (CRS); no patients experienced Grade 3-5 CRS
- No immune effector cell-associated neurotoxicity syndrome (ICANS) or other neurotoxicity of any grade had been observed
"This clinical data brings us great optimism. GC012F has demonstrated an impressive 100% ORR, 100% MRD negativity and 87.5% sCR, as well as an outstanding safety profile, among newly-diagnosed multiple myeloma patients, showing tremendous potential for substantial improvement over currently available therapies," said Dr.
GC012F is a FasTCAR-enabled BCMA/CD19 dual-targeting CAR-T product candidate that is currently being evaluated in IIT studies in
CAR-T cells manufactured on Gracell's proprietary FasTCAR platform appear younger, less exhausted and show enhanced proliferation, persistence, bone marrow migration and tumor cell clearance activities as demonstrated in preclinical studies. With next-day manufacturing, FasTCAR is able to significantly improve cell production efficiency which may result in meaningful cost savings, and, together with fast release time, enables enhanced accessibility of cell therapies for cancer patients.
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