CARTITUDE-1 — Ciltacabtagene Autoleucel (Cilta-cel), a BCMA CAR-T Therapy, in Relapsed/Refractory Multiple Myeloma (CARTITUDE-1)

Phase 1b/2 · 2021 · Multiple Myeloma

Design

Single-arm, open-label trial of a single cilta-cel infusion after lymphodepleting chemotherapy.

Population

Relapsed/refractory multiple myeloma after at least three prior lines including a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 antibody.

Primary Endpoint

overall response rate (ORR)

Key Result

ORR 97% with 67% stringent complete response; responses were deep and durable with median PFS not reached at ~28 months.

Guideline Impact

FDA-approved 2022 (subsequently moved to earlier lines); NCCN-listed for relapsed/refractory multiple myeloma