Carvykti (ciltacabtagene autoleucel)

P4, N=295, Recruiting, Janssen Research & Development, LLC | Trial completion date: Jan 2038 --> Jun 2042

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

We report a case of minimal change disease presenting with AKI and nephrotic-range proteinuria 3 weeks after B-cell maturation antigen-directed CAR-T cell therapy, ciltacabtagene autoleucel, in a patient with relapsed refractory multiple myeloma. The patient received one dose of rituximab along with a short course of corticosteroid and had complete kidney recovery by week 4 of therapy. This report emphasizes the need for further investigation into the mechanism of kidney toxicity following CAR-T cell therapy, and potential benefits and risks of immunosuppressive therapy in this context.

P1, N=52, Not yet recruiting, Washington University School of Medicine | N=40 --> 52

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.

P4, N=75, Not yet recruiting, Universitair Ziekenhuis Gent

P1, N=40, Not yet recruiting, Washington University School of Medicine | Trial completion date: Jul 2028 --> Nov 2028 | Initiation date: Jan 2026 --> May 2026 | Trial primary completion date: Oct 2027 --> Feb 2028

P2, N=60, Recruiting, Janssen Research & Development, LLC | Trial primary completion date: Jan 2028 --> Apr 2028

P1, N=16, Recruiting, Washington University School of Medicine | N=12 --> 16 | Trial completion date: Mar 2027 --> May 2028 | Trial primary completion date: Apr 2026 --> Jun 2027

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.

In this issue of Cancer Cell, Rade et al. report a longitudinal single-cell atlas of multiple myeloma patients receiving BCMA-directed chimeric antigen receptor (CAR) T cell therapy (ide-cel or cilta-cel) and identifiy features linked to long-term responses, including CD4+ T cell-driven cytotoxicity, memory-biased T cell states, reduced exhaustion, and microenvironment effects.

P2, N=60, Recruiting, Janssen Research & Development, LLC | Trial completion date: Dec 2028 --> Apr 2029