CARTITUDE-2 is a multi-cohort Phase 2 study of the BCMA-directed CAR-T therapy ciltacabtagene autoleucel (cilta-cel, Carvykti) in earlier-line multiple myeloma — including lenalidomide-refractory patients after 1-3 prior lines, early relapse, and suboptimal response after transplant. It produced deep responses (ORR up to 95%; high MRD-negativity) but is a supportive, non-pivotal study, not the basis of FDA approval. Sponsor: Janssen / Legend Biotech.
Discover KOL Sentiment on CARTITUDE-2 →Design — Multi-cohort Phase 2; ciltacabtagene autoleucel (Carvykti) in earlier-line multiple myeloma — Cohort A (1-3 prior lines, len-refractory), Cohort B (early relapse), Cohort D (post-ASCT suboptimal response) (NCT04133636). (ASH 2023 / ASCO 2024)
Cohort A — ORR 95% (initial) / 91% (expansion); 100% MRD-negativity at 10^-5 in evaluable patients; 24-month PFS 75%. (ASH 2023)
Cohort B — 74% stringent complete response; 93% MRD-negative at 10^-5; 24-month PFS 73%. (ASH 2023)
Overall survival — Medians not reached across cohorts A/B (median follow-up ~29 months); Cohort A 12-month OS 91%. (ASH 2023)
Safety — CAR-T class effects (cytokine release syndrome, ICANS, delayed/non-ICANS neurotoxicity) managed per CARVYKTI REMS; no new safety signals versus CARTITUDE-1. (ASH 2023)
Regulatory / Sponsor — SUPPORTIVE, non-pivotal — not the basis of FDA approval; cilta-cel's approvals rest on CARTITUDE-1 and CARTITUDE-4. Janssen / Legend Biotech. (FDA label)
Compiled and reviewed by the KOL Pulse research team, led by Brian Shields, Founder, KOL Pulse. Last updated July 21, 2026.
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Summer of the CARTITUDE programs for Cilta Cel https://t.co/u3Wm2uAxPB
“📊 Impact of Prior BCMA-Targeted Therapies on CAR T-Cell Outcomes
🔹 CARTITUDE-2 Cohort C:
•Evaluated Cilta-Cel after PI, IMiD, CD38 mAb, and BCMA-targeted therapy.
•Best ORR:
•Full cohort:…
For US HCPs at #IMS25, see Dr. Yael Cohen present updated results from CARTITUDE-2, Cohort D of a BCMA-directed #CART therapy +/- lenalidomide maintenance for multiple myeloma patients with a…
CARTITUDE-2 provides cohort-specific evidence for cilta-cel in earlier treatment lines (including len-refractory mm post-1-3 lines and post-ASCT suboptimal responders). Complements CARTITUDE-4 pivotal phase 3 which established the ≥1 prior line approval. Informs clinical decision-making for patient selection.
Cohort A (len-refractory, 1-3 prior lines): ORR 95% (initial)/91% (expansion), 100% MRD negativity at 10⁻⁵ in evaluable patients, 24-month PFS 75%. Cohort B (early relapse): deep responses including 74% sCR, 93% MRD-negative at 10⁻⁵, 24-month PFS 73%. Cohort D (post-ASCT suboptimal response): 36-month outcomes reported with favorable PFS/OS.
Medians not reached across cohorts A/B (median follow-up ~29 months). Cohort A 12-month OS 91%; Cohort B 24-month OS 75-84%. Long-term follow-up continues.
Key AEs: Cytokine release syndrome (CRS), ICANS, other neurotoxicities. Most CRS and ICANS events resolved across all cohorts. No new CAR-T safety signals vs. CARTITUDE-1. Delayed non-ICANS neurotoxicities (movement and neurocognitive events) remain a CARVYKTI class effect requiring monitoring.
⚠️ Supportive phase 2 data — not the basis of FDA approval. CARTITUDE-2 provides cohort-specific evidence for cilta-cel in earlier treatment lines (including len-refractory mm post-1-3 lines and post-ASCT suboptimal responders). Complements CARTITUDE-4 pivotal phase 3 which established the ≥1 prior line approval. Informs clinical decision-making for patient selection.
CARTITUDE-2 (NCT04133636) is a multi-cohort Phase 2 study of the BCMA-directed CAR-T therapy ciltacabtagene autoleucel (cilta-cel, Carvykti) in earlier-line multiple myeloma. Its cohorts include lenalidomide-refractory patients after 1-3 prior lines (Cohort A), early relapse after initial therapy (Cohort B), and suboptimal response after autologous transplant (Cohort D). It is sponsored by Janssen / Legend Biotech.
CARTITUDE-2 produced deep, durable responses. In Cohort A, overall response rate was 95% (initial) / 91% (expansion) with 100% MRD-negativity at 10^-5 in evaluable patients and 24-month PFS of 75%. In Cohort B (early relapse), 74% achieved stringent complete response, 93% were MRD-negative at 10^-5, and 24-month PFS was 73%.
No. CARTITUDE-2 is a supportive, non-pivotal Phase 2 study. Cilta-cel (Carvykti) is FDA approved for relapsed or refractory multiple myeloma after at least one prior line based on the Phase 3 CARTITUDE-4 trial (expanded April 2024), with the initial accelerated approval (February 2022, four or more prior lines) based on CARTITUDE-1. CARTITUDE-2's cohorts are exploratory.
CARTITUDE-2 provides cohort-specific evidence for cilta-cel in earlier treatment settings — including lenalidomide-refractory disease after 1-3 prior lines and suboptimal responders after transplant — complementing the pivotal CARTITUDE-1 and CARTITUDE-4 trials and informing how CAR-T might be positioned across the myeloma treatment course.
Safety was consistent with the known cilta-cel profile: cytokine release syndrome, ICANS and other neurotoxicities, including delayed non-ICANS movement and neurocognitive events that are a recognized CARVYKTI class effect. Most CRS and ICANS events resolved, and no new safety signals emerged relative to CARTITUDE-1; events are managed under the CARVYKTI REMS.