Carvykti (ciltacabtagene autoleucel)

P2/3, N=440, Recruiting, European Myeloma Network B.V., Emn Trial Office S.r.l. Impresa Sociale | Not yet recruiting --> Recruiting

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

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.

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