Ciltacabtagene Autoleucel (cilta-cel)

CARVYKTI®

Overview

CARVYKTI™ (ciltacabtagene autoleucel) is a BCMA-directed, genetically modified autologous T-cell immunotherapy, which involves reprogramming a patient’s own T-cells with a transgene encoding a chimeric antigen receptor (CAR) that identifies and eliminates cells that express the B-cell maturation antigen (BCMA). BCMA is primarily expressed on the surface of malignant multiple myeloma B-lineage cells, as well as late-stage B-cells and plasma cells. The CARVYKTI™ CAR protein features two BCMA-targeting single domain antibodies designed to confer high avidity against human BCMA. Upon binding to BCMA-expressing cells, the CAR promotes T-cell activation, expansion, and elimination of target cells.

SparkCures ID 328
Developed By Janssen Research & Development
Brand Name Carvykti®
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.

Verified
Phase 2, Open-Label Study Evaluating the Use of an investigational CAR-T Cell therapy in Participants with Multiple Myeloma
CARTITUDE-2
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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.

Verified
Phase 2, Open-Label Study Evaluating the Use of an investigational CAR-T Cell therapy in Participants with Multiple Myeloma
CARTITUDE-2
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Verified
A Study of Whether Ide-cel (bb2121) Can Be Made From People With Multiple Myeloma Who Have Had a Hematopoietic Cell Transplant
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Smoldering Myeloma

The following is a listing of clinical trials for patients with Smoldering Myeloma.

CAR- PRISM (PRecision Intervention Smoldering Myeloma)
CAR-PRISM
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Monoclonal Gammopathy of Undetermined Significance (MGUS)

Published Results

Cilta-cel Elicits an ORR of 100% in Multiple Myeloma After Early Relapse on Initial Therapy

June 24, 2022

At a median follow-up of 13.4 months (range, 5.2-21.7), cilta-cel produced an overall response rate (ORR) of 100% (95% CI, 82.4%-100%) in 19 patients; 90% of patients achieved a complete response (CR) or better and 95% had a very good partial response (VGPR) or better. The CAR T-cell therapy resulted in a partial response rate of 5%, and a stringent CR of 63%.

Levels of IL-6 and IFN-γ increased following infusion of cilta-cel, peaking at days 7 through 14 and returning to baseline levels within 2 to 3 months. Notably, the incidence of cytokine release syndrome (CRS) was associated with a higher peak of IL-6 and IFN-γ.

CRS was reported in 84% of patients; 1 patient had grade 3/4 CRS. The median time to onset of CRS was 8 days (range, 5-11), and the median duration was 3.5 days (range, 1-7). Additionally, 63% of patients received tocilizumab (Actemra) and 21% were given corticosteroids for CRS. This toxicity was resolved in all patients.

Neurotoxicity was reported in 26% of patients, and it had resolved in 3 of 5 patients. One patient experienced grade 1 immune effector cell–associated neurotoxicity syndrome, with a time to onset of 11 days and a duration of 4 days. Another patient experienced grade 3 movement and neurocognitive treatment-emergent adverse effects (MNTs)/parkinsonism that occurred at day 38. Notably, this patient had at least 2 risk factors for MNTs/parkinsonism, and they showed improvement at the time of data cutoff and achieved a CR.

Regarding other safety data, hematologic adverse effects (AEs) of any grade included neutropenia (95%), anemia (58%), thrombocytopenia (58%), lymphopenia (32%), and leukopenia (26%).

Grade 3 or 4 hematologic AEs included neutropenia (90%), anemia (47%), thrombocytopenia (26%), lymphopenia (32%), and leukopenia (26%). Notably, the rate of grade 3/4 cytopenias that did to not improve to grade 2 or less by day 60 was 16% for thrombocytopenia, 11% for lymphopenia, and 11% for neutropenia.

One death occurred on the study, due to progressive disease on day 158. For the 1 patient treated in an outpatient setting, the safety profile of cilta-cel was found to be manageable.

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