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

Janssen Reports New Data for BCMA CAR-T, Cilta-Cel, Showing Deep and Durable Responses in Patients with Relapsed or Refractory Multiple Myeloma

June 02, 2021

CARTITUDE-1

The Janssen Pharmaceutical Companies of Johnson & Johnson today announced new data for ciltacabtagene autoleucel (cilta-cel), an investigational B-cell maturation antigen (BCMA)-directed CAR-T therapy, demonstrated sustained efficacy and durable responses in heavily pretreated patients with relapsed/refractory multiple myeloma (RRMM). Updated results from the Phase 1b/2 CARTITUDE-1 study (n=97) with a longer-term follow-up at a median of 18 months showed an overall response rate (ORR) of 98 percent, with 80 percent of patients achieving a stringent complete response (sCR), highlighting a deepening response over time (increasing from 67 percent presented at ASH 2020).

CARTITUDE-2

Findings from Cohort A (n=20) in the Phase 2 CARTITUDE-2 (NCT04133636) study evaluating the safety and efficacy of cilta-cel in patients with multiple myeloma whose disease progressed after one to three prior lines of therapy, and who were lenalidomide refractory, will be presented for the first time at ASCO (Abstract #8013) and as an oral presentation at the European Hematology Association (EHA) Congress (Abstract #S190). Results from this cohort showed early and deep responses at a median of 5.8 months of follow-up2, and an ORR of 95 percent with 45 percent of patients achieving a sCR, 30 percent of patients achieving a CR, 10 percent of patients achieving a VGPR, and 10 percent of patients achieving a PR.2 The overall safety profile, including incidence of CRS and most common hematologic AEs, was consistent with observations in the CARTITUDE clinical development program.

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