|Videos|January 27, 2022

Cilta-Cel in the Multiple Myeloma Treatment Landscape: Thomas G. Martin, MD

Therapy Status

Carvykti (ciltacabtagene autoleucel)

Johnson & Johnson / Legend Biotech

Approved — r/r myeloma, ≥1 prior line Boxed warnings incl. secondary malignancy As of August 28, 2026

Approved for relapsed/refractory multiple myeloma after at least 1 prior line of therapy (lenalidomide-refractory). Boxed warnings cover CRS, ICANS, Parkinsonism/GBS, HLH/MAS, prolonged cytopenias, immune effector cell-associated enterocolitis (added October 2025), and secondary hematologic malignancies. The CAR-T REMS program was eliminated in June 2025.

  1. February 28, 2022 · FDA approval for r/r multiple myeloma after ≥4 prior lines
  2. April 19, 2024 · Class-wide boxed warning added: secondary T-cell malignancy
  3. June 26, 2025 · FDA eliminates REMS for approved CAR-T therapies
  4. October 10, 2025 · Boxed warning added: immune effector cell-associated enterocolitis Latest

The clinical professor of medicine, Helen Diller Family Comprehensive Cancer Center, UCSF, discussed data from both the CARTITUDE-1 and CARTITUDE-2 studies.

Ciltacabtagene autoleucel (cilta-cel) produced deep and durable responses in heavily-pretreated patients with multiple myeloma, according to data from the phase 1/2 CARTITUDE-1 study (NCT03548207).1,2

These data were presented at the 63rd Annual American Society of Hematology (ASH) Meeting, December 11-14, 2021, by Thomas G. Martin, MD, clinical professor of medicine, Adult Leukemia and Bone Marrow Transplantation Program, and associate director, Myeloma Program, University of California San Francisco, and co-leader, Cancer Immunology & Immunotherapy Program, Helen Diller Family Comprehensive Cancer Center.

Also presented at ASH 2021 were results from the CARTITUDE-2 study (NCT04133636) which is evaluating cilta-cel as an earlier line of therapy in patients with only 1 to 3 prior lines of therapy.3 Progression-free survival (PFS) at 6 months was 90% (95% CI, 65.6–97.4).

GeneTherapyLive spoke with Martin to learn more about the CARTITUDE-1 and CARTITUDE-2 studies. He discussed positive safety and efficacy data seen in both studies and cilta-cel's place in the multiple myeloma treatment landscape.

REFERENCES
1. New data from CARTITUDE-1 Study show continued deep and durable responses of ciltacabtageneautoleucel (cilta-cel) in treatment of heavily pretreated patients with multiple myeloma. News release. Janssen. December 12, 2021. https://www.janssen.com/new-data-cartitude-1-study-show-continued-deep-and-durable-responses-ciltacabtagene-autoleucel-cilta
2. Martin T, Usmani SZ, Berdeja JG, et al. Updated results from CARTITUDE-1: Phase 1b/2 study of CiltacabtageneAutoleucel, a B-cell maturation antigen–Directed chimeric antigen receptor T cell therapy, in patients with relapsed/refractory multiple myeloma. Presented at: 63rd Annual ASH Meeting; December 11-14, 2021, Atlanta, GA. Abstract 549.
3. Cohen YC, Cohen DA, Delforge M, et al. Efficacy and safety of ciltacabtageneautoleucel (cilta-cel), a B-cell maturation antigen (BCMA)–directed chimeric antigen receptor (CAR) T-cell therapy, in lenalidomide-refractory patients with progressive multiple myeloma after 1–3 prior lines of therapy: Updated results from CARTITUDE-2. Presented at: 63rd Annual ASH Meeting; December 11-14, 2021, Atlanta, GA. Abstract 3866.

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