
Cilta-Cel Safety Profile in Multiple Myeloma: Adam D. Cohen, MD
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.
- October 10, 2025 · Boxed warning added: immune effector cell-associated enterocolitis Latest
The director of Myeloma Immunotherapy at University of Pennsylvania discussed ciltacabtagene autoleucel's safety profile.
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OncLive spoke with Adam D. Cohen, MD, assistant professor of medicine and director, Myeloma Immunotherapy, University of Pennsylvania, to learn more about the safety profile of ciltacabtagene autoleucel (cilta-cel) in patients with multiple myeloma.
Cohen discussed safety data from the phase 2 CARTITUDE-2 study (NCT04133636). The study found that the main hematologic toxicities observed with cilta-cel were similar to those reported in the phase 1/2 CARTITUDE-1 trial (NCT03548207). These included neutropenia, anemia, and thrombocytopenia, according to Cohen. These toxicities are most often associated with lymphodepletion conditioning therapy, as well as the CAR T-cell therapy itself, Cohen explains.
The rates of grade 3/4 thrombocytopenia and anemia appeared to be less than what was reported on CARTITUDE-1, and prolonged grade 3/4 cytopenias also occurred less frequently; this may be because the CARTITUDE-2 study enrolled a less heavily pretreated population, Cohen concludes.
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