According to research presented by Luciano Costa, MD, University of Alabama at Birmingham, Birmingham, Alabama, at the 2025 American Society of Hematology (ASH) Annual Meeting & Exposition in Orlando, Florida, ciltacabtagene autoleucel (cilta-cel) yields highly durable responses and prolonged progression-free survival (PFS) among patients with relapsed/refractory (R/R) multiple myeloma (MM) as a second-line therapy.

Researchers conducted the phase 3 CARTITUDE-4 trial (NCT04181827) to evaluate the safety and efficacy of ciltacabtagene autoleucel, a BCMA-directed CAR T-cell therapy, for patients with standard-risk cytogenetics. 

Patients were randomized to receive ciltacabtagene autoleucel following bridging therapy with pomalidomide, bortezomib, and dexamethasone (PVd) or daratumumab, pomalidomide, and dexamethasone (DPd), lymphodepletion, and a single CAR-T infusion. High-risk cytogenetic features which were defined as del(17p), t(14;16), t(4;14), or 1q gain/amp were excluded from the as-treated subgroup.

Overall, 208 patients were included and 176 patients completed treatment. The median follow-up as 33.6 months. The 30-month PFS rate was 80.5% (95% confidence interval [CI], 67.2 to 88.8).

Following ciltacabtagene autoleucel infusion, 8 PFS events occurred within the first year and 4 occurred beyond 1 year. A minimal-residual disease (MRD) negative complete response (CR) was achieved by 26 patients. Additionally, 100% of these patients remained progression free at 30 months.

The researchers concluded, “The low rate of progression events in cilta-cel treated patients with standard-risk cytogenetics shows the profound benefit of a single cilta-cel infusion in this population.”

Source: 

Costa L, Oriol A, Dytfeld D, et al. Long-term progression-free survival benefit with ciltacabtagene autoleucel in standardrisk relapsed / refractory multiple myeloma. Dec 6-9, 2025; Orlando, FL. Abstract: 94