Abecma (idecabtagene vicleucel)

These findings provide a signal supporting the feasibility and safety of bendamustine-based lymphodepletion and highlight the prognostic relevance of renal function in Cilta-Cel-treated patients. While Cilta-Cel generally confers superior efficacy compared with Ide-Cel, this advantage may be attenuated in patients with moderate/severe CKD, potentially due to competing risks such as frailty, early toxicity, or impaired cellular fitness.

Wearable devices are feasible for early CRS detection and may support outpatient CAR-T care. Larger outpatient studies are warranted.

P1, N=15, Recruiting, City of Hope Medical Center | Trial completion date: Mar 2026 --> Sep 2026 | Trial primary completion date: Mar 2026 --> Sep 2026

P2, N=24, Active, not recruiting, Memorial Sloan Kettering Cancer Center | Recruiting --> Active, not recruiting

Two patients who had relapsed after CAR T-cell treatment with idecabtagene vicleucel achieved partial and very good partial responses and were successfully transitioned to a second CAR T-cell therapy with ciltacabtagene autoleucel. SVd demonstrates meaningful activity in patients with penta-refractory MM and prior failure of BCMA/GPRC5D-targeted immunotherapies. The ORR of 61%, disease control in 78% of patients, and median PFS of 4.3 months support further evaluation of SVd in this highly refractory setting after failure of BCMA- and GPRC5D-directed approaches.

ORR was 75.4% (95% CI, 63.1-85.2) and CRR was 35.4% (95% CI, 23.9-48.2). The manufacturing success of ide-cel is reliable and consistently high, and when OOS ide-cel products emerged, they demonstrated consistent clinical efficacy and safety.

P2/3, N=312, Recruiting, Celgene | N=214 --> 312

P2, N=32, Recruiting, Massachusetts General Hospital | Trial primary completion date: Dec 2025 --> Aug 2026

P3, N=79, Active, not recruiting, Celgene | N=618 --> 79 | Trial completion date: Aug 2025 --> Nov 2029

P2, N=312, Completed, Celgene | Active, not recruiting --> Completed | Trial completion date: Oct 2025 --> Jan 2026 | Trial primary completion date: Oct 2025 --> Jan 2026

MSK AEs represent a common, under-recognized toxicity affecting nearly one-third of BCMA CAR-T recipients, often causing severe and prolonged disability. The identification of predictive baseline PMN-MDSC reduction and persistent inflammatory cytokine elevation provides insights into pathophysiology and suggests potential for risk stratification and targeted therapeutic intervention. These findings warrant prospective validation and development of standardized assessment and management protocols.

P1/2, N=15, Recruiting, Universitaetsklinikum Erlangen AR