
Safety Profile of Cilta-Cel: Saad Z. Usmani, MD, MBA, FACP
Therapy Status
Carvykti (ciltacabtagene autoleucel)
Johnson & Johnson / Legend Biotech
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.
- February 28, 2022 · FDA approval for r/r multiple myeloma after ≥4 prior lines
- April 19, 2024 · Class-wide boxed warning added: secondary T-cell malignancy
- June 26, 2025 · FDA eliminates REMS for approved CAR-T therapies
- October 10, 2025 · Boxed warning added: immune effector cell-associated enterocolitis Latest
The director of Clinical Research in Hematologic Malignancies at Levine Cancer Institute discussed adverse events in the CARTITUDE-1 trial.
This content originally appeared on our sister site,
CancerNetwork® spoke with Saad Z. Usmani, MD, MBA, FACP, of the Levine Cancer Institute in Charlotte, North Carolina, to discuss the safety profile of the phase 1b/2
Transcription:
For CARTITUDE-1, there were no new safety updates because the more common adverse events that we observe with CAR T-cell therapies—not just with the previously reported [B-cell maturation antigen]–directed CAR T-cells, but also with CD19 CAR T-cells—[are] hematologic AEs. Those were quite common and consistent with what has been reported in the past. The same is true for [cytokine release syndrome (CRS)]. Ninety-two patients out of the 97 had CRS, but most of those were grade 1 or grade 2, and CRS resolved in 99% of the patients within 14 days of onset.















