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).

SparkCures ID 328
Developed By Johnson & Johnson
Brand Name Carvykti®
Generic Name Ciltacabtagene Autoleucel (cilta-cel)
Additional Names JNJ-68284528, LCAR-B38M
Treatment Classifications
Treatment Targets

Clinical Trials

All Clinical Trials

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Untreated / Newly Diagnosed Multiple Myeloma

The following is a listing of clinical trials for patients with multiple myeloma who have been newly diagnosed or have not yet received treatment.

Verified
A Phase 2, Open-Label, Multicenter Study of Ciltacabtagene Autoleucel and Talquetamab for the Treatment of Participants With High-Risk Multiple Myeloma
MONUMENTAL-8
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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.

Cilta-Talq Fusion Study: A Phase 1b Study of Talquetamab Bridging Therapy Followed by Ciltacabtagene Autole...
CILTA-TALQ FUSION STUDY
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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
A Study to See if Anti-BCMA CAR T-Cell Therapy Can Be Made from People with Multiple Myeloma Who Have Had a Stem Cell Transplant
CAR T POST HEMATOPOIETIC CELL TRANSPLANT
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Verified
A Phase 2, Open-Label, Multicenter Study of Ciltacabtagene Autoleucel and Talquetamab for the Treatment of Participants With High-Risk Multiple Myeloma
MONUMENTAL-8
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DART: Phase II Study of Dasatinib and Quercetin in Patients With Relapsed, Refractory Multiple Myeloma Rece...
DASATINIB & QUERCETIN WITH CAR-T CELL THERAPY
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Cilta-Talq Fusion Study: A Phase 1b Study of Talquetamab Bridging Therapy Followed by Ciltacabtagene Autole...
CILTA-TALQ FUSION STUDY
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Smoldering Myeloma
Monoclonal Gammopathy of Undetermined Significance (MGUS)

Published Results

The Phase 2 CARTITUDE-2 Trial: Updated Efficacy and Safety of Ciltacabtagene Autoleucel in Patients with Multiple Myeloma and 1-3 Prior Lines of Therapy (Cohort A) and with Early Relapse after First Line Treatment (Cohort B)

November 28, 2023

As of April 2023, 20 patients in cohort A had received cilta-cel (median follow-up, 29.9 months; 35% with high-risk cytogenetics; median 2 prior LOT; 95% refractory to last LOT; 40% triple-class refractory; 85% with prior ASCT). At the same data cut-off, 19 patients in cohort B hadreceived cilta-cel (median follow-up, 27.9 months; 16% with high-risk cytogenetics; 79% refractory to last LOT; 16% triple-class refractory; 79% with prior ASCT). All (100%) 17 MRD-evaluable patients in cohort A and 14 (93%) of 15 MRD-evaluable patients in cohort B achieved MRD negativity (10 -5 threshold). Eight (40%) of 20 patients in cohort A and 10 (53%) of 19 patients in cohort B sustained MRD negativity at 10 -5 for ≥6 months (Table 1). In the 20 patients in cohort A and 19 in cohort B, cilta-cel led to overall response rates of 95% (complete response or better [≥CR], 90%) and 100% (≥CR, 90%), respectively. Median PFS was not reached in either cohort, and 24-month PFS rates were 75% in cohort A and 73% in cohort B; respective 24-month overall survival rates were 75% and 84%. In cohort A, hematologic treatment-emergent adverse events (TEAEs) occurring between 17.1- and 29.9-month median follow-up included maximum grade (gr) 3/4 leukopenia in 1 patient (all gr,12 total; 60%), maximum gr 3/4 lymphopenia in 2 patients (all gr,16 total; 80%), and maximum gr 3/4 thrombocytopenia in 1 patient (all gr,16 total; 80%). In cohort B, no new patients reported hematologic TEAEs between 18.0- and 27.9-month median follow-up (Table 2). In cohort A, no new patients had CAR-T cell neurotoxicity, and no patients had a second primary malignancy (SPM). In cohort B, no new patients had MNTs, but other neurotoxicity (gr 2 sensory loss) occurred in 1 additional patient (all gr, 5 total; 26%) and resolved; and SPM (gr 4 choroid melanoma) occurred in 1 additional patient (all gr, 2 total; 11%). One new death (total 5) occurred in cohort A on day 666 due to progressive disease, and 1 new death (total 4) occurred in cohort B on day 749 due to cardiac arrest (not treatment related).

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