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A single infusion of BCMA-directed CAR-T cells produced responses in 97% of patients whose myeloma had failed a median of six prior lines, with two-thirds reaching stringent complete response.
CARTITUDE-1 was a phase 1b/2 single-arm study of ciltacabtagene autoleucel (cilta-cel), a CAR-T with two BCMA-binding domains, in 97 patients with relapsed or refractory multiple myeloma exposed to a proteasome inhibitor, an immunomodulatory drug and an anti-CD38 antibody (median six prior lines, 88% triple-class refractory). The overall response rate was 97%, with stringent complete response in 67%; 12-month PFS was 77% and OS 89%. Cytokine release syndrome occurred in 95% (grade 3-4 in about 4%) and neurotoxicity in about 21%, including a small number of delayed movement and neurocognitive events. Long-term follow-up showed roughly a third of patients progression-free at five years without further therapy, unprecedented in this population.
CARTITUDE-1 showed that a single CAR-T infusion can put late-stage myeloma into deep, multi-year remission, leading to FDA approval of cilta-cel in 2022 for heavily pretreated disease. It set the efficacy bar for BCMA-directed therapy and motivated moving CAR-T earlier (CARTITUDE-4). Late neurological toxicity and secondary malignancies remain the safety questions.
Shares Legend Biotech, CARTITUDE-1, Ciltacabtagene autoleucel, BCMA.
Shares Legend Biotech, Ciltacabtagene autoleucel, ICANS (neurotoxicity), BCMA.
Shares Legend Biotech, CARTITUDE-4: cilta-cel CAR-T versus standard combinations after one to three prior lines of myeloma therapy, Ciltacabtagene autoleucel, Johnson & Johnson.
Shares Legend Biotech, CARTITUDE-1, Ciltacabtagene autoleucel.
Shares CARTITUDE-4: cilta-cel CAR-T versus standard combinations after one to three prior lines of myeloma therapy, BCMA, Objective response rate (ORR), Cytokine release syndrome (CRS).
Shares CARTITUDE-4: cilta-cel CAR-T versus standard combinations after one to three prior lines of myeloma therapy, Ciltacabtagene autoleucel, Johnson & Johnson, Multiple myeloma.
Shares Ciltacabtagene autoleucel, Johnson & Johnson, CAR-T cell therapy, Multiple myeloma.
Shares Ciltacabtagene autoleucel, Johnson & Johnson, CAR-T cell therapy, Multiple myeloma.