Ciltacabtagene Autoleucel (cilta-cel)

Overview

Ciltacabtagene autoleucel (cilta-cel; JNJ-68284528; LCAR-B38M CAR-T cells) is an autologous CAR-T therapy that targets B-Cell Maturation Antigen (BCMA), a molecule expressed on the surface of mature B lymphocytes and malignant plasma cells. The investigational therapy expresses an identical CAR protein as Legend's LCAR-B38M CAR-T product, which was evaluated in a first-in-human clinical study (Legend-2) conducted in multiple sites by Legend Biotech in China.

SparkCures ID 328
Developed By Janssen Research & Development
Generic Name Ciltacabtagene Autoleucel (cilta-cel)
Additional Names JNJ-68284528, LCAR-B38M
Treatment Classifications
Treatment Targets

Clinical Trials

All Clinical Trials

View all active clinical trials around the US.

Early Relapse Multiple Myeloma

The following is a listing of clinical trials for patients with multiple myeloma who have received one to two prior lines of therapy.

Late Relapse Multiple Myeloma

The following is a listing of clinical trials for patients with multiple myeloma who have received three or more prior lines of therapy.

Smoldering Myeloma
Monoclonal Gammopathy of Undetermined Significance (MGUS)

Published Results

Phase 1b/2 Study of Ciltacabtagene Autoleucel, a B-Cell Maturation Antigen–Directed Chimeric Antigen Receptor T Cell Therapy, in Relapsed/Refractory Multiple Myeloma

December 02, 2020

As of the May 20, 2020 clinical cutoff, 97 pts (58.8% male; median age 61.0 y [range 43–78]) with R/R MM received cilta-cel (29 in phase 1b; 68 in phase 2). Median follow-up duration was 8.8 mo (range 1.5–20.4). Pts had received a median of 6 prior lines of therapy (range 3–18); 83.5% were penta-exposed, 87.6% were triple-refractory, 41.2% were penta-refractory, and 97.9% were refractory to last line of therapy. Overall response rate per independent review committee (primary endpoint) was 94.8% (95% CI 88.4–98.3), with a stringent complete response rate of 55.7% (95% CI 45.2–65.8), very good partial response rate of 32.0% (95% CI 22.9–42.2), and partial response rate of 7.2% (95% CI 3.0–14.3). All pts achieved a reduction in M-protein. Median time to first response was 1.0 mo (range 0.9–5.8; 80.4% ≤1.0 mo), and median time to complete response or better was 1.8 mo (range 0.9–12.5; 74.1% ≤3.0 mo); responses deepened over time (Figure). Median duration of response was not reached (NR). Of 52 MRD-evaluable pts, 94.2% were MRD-negative at 10-5. The 6-mo progression-free survival (PFS) and overall survival (OS) rates (95% CI) were 87.4% (78.9–92.7) and 93.8% (86.7–97.2), respectively; median PFS and OS were NR. Ten deaths occurred during the study; 8 were due to AEs (both related and unrelated; CRS/hemophagocytic lymphohistiocytosis, neurotoxicity, respiratory failure, sepsis, septic shock, pneumonia, lung abscess, and acute myelogenous leukemia [n=1 each]), and 2 due to progressive disease. AEs reported in >70% of pts were CRS (94.8%; grade [gr] 3/4 4.1%), neutropenia (90.7%; gr 3/4 90.7%), anemia (81.4%; gr 3/4 68.0%), and thrombocytopenia (79.4%; gr 3/4 59.8%). Median time to CRS onset was 7.0 d (range 1–12) and median duration 4.0 d (range 1–27, excluding n=1 with 97 d). CAR-T cell–related neurotoxicity was reported in 20.6% of pts (gr 3/4 10.3%). Cilta-cel CAR+ T cells showed maximum peripheral expansion at 14 d (range 9–43). Among pts with 6 mo’ individual follow-up, 67% had cilta-cel CAR+ T cells below the level of quantification (2 cells/µL) in peripheral blood.

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