Single-center phase 1 trial of BCMA/CD19 dual-targeting CAR T-cell therapy for newly diagnosed multiple myeloma

Patients with high-risk newly diagnosed multiple myeloma (NDMM) often have poor outcomes with standard treatments. GC012F is a BCMA/CD19 dual-targeting CAR T-cell therapy. A phase 1 trial at Shanghai Changzheng Hospital (China) evaluated frontline GC012F in patients with high-risk NDMM who were eligible for transplant. In this study including 19 patients in the efficacy analysis, all patients (100%) achieved stringent complete responses and minimal residual disease negativity. In the 22 patients in the safety analysis, the treatment showed a favorable safety profile, with 6 patients (27%) experiencing mild to moderate cytokine release sydrome and no patients experiencing immune effector cell-associated neurotoxicity syndrome. The authors conclude that GC012F is a safe treatment with favorable efficacy among patients with high-risk NDMM eligible for transplant following initial induction therapy.