Phase I Study: Dual Targeting BCMA & CD19 FASTCAR-T for High-Risk Multiple Myeloma

Dr. Juan Du presents the results of a phase I study evaluating the safety and efficacy of GC012F, a dual-targeting BCMA and CD19 CAR-T therapy, as first-line therapy for transplant-eligible high-risk newly diagnosed multiple myeloma (NDMM) patients. The study included 22 patients with high-risk features, and the results showed that GC012F achieved deep and durable responses, with a 100% overall response rate (ORR) and a 95.5% stringent complete response (sCR) rate. All treated patients achieved minimal residual disease (MRD) negativity, and the median duration of response (DOR) and progression-free survival (PFS) were not reached. The safety profile of GC012F was favorable, with low-grade cytokine release syndrome (CRS) observed in only 27% of patients and no severe CRS or ICANS. These promising findings highlight the potential of CAR-T therapy in treating high-risk NDMM patients and suggest the need for further research to confirm these results and address the unmet medical need in this patient population.
Key Points:
- High-risk newly diagnosed multiple myeloma (NDMM) patients often have poor outcomes with standard first-line therapies.
- GC012F is a dual-targeting BCMA and CD19 CAR-T therapy developed using the FasTCAR-T platform.
- The phase I study aimed to characterize the safety and feasibility of GC012F CAR-T cell therapy in transplant-eligible high-risk NDMM patients.
- Twenty-two evaluable patients with high-risk features were treated with GC012F.
- The overall response rate (ORR) was 100% and the stringent complete response (sCR) rate was 95.5%.
- All treated patients achieved minimal residual disease (MRD) negativity.
- The median duration of response (DOR) and progression-free survival (PFS) were not reached.
- The PFS rate at 18 months was 95.45%.
- Only 27% of patients experienced low-grade cytokine release syndrome (CRS), with no grade ≥3 CRS or ICANS observed.
- Robust CAR T-cell expansion was observed in all patients.
- The promising preliminary results demonstrate the potential of CAR-T therapy in treating NDMM patients.
- Further research involving a larger patient population and longer follow-up periods is needed to confirm these findings and address the unmet medical need in NDMM.
Authors:
Juan Du, Wanting Qiang, Jing Lu, Yanchun Jia, Haiyan He, Jin Liu, Pei Guo, Ying Yang, Zhongyuan Feng, Lina Jin, Xiaoqiang Fan, Jia Liu, Qi Zhang, Lihong Weng, Lianjun Shen, Wenling Li, Wei Cao
EHA Abstract: S200
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