Cilta-cel is the common short name for ciltacabtagene autoleucel, an autologous BCMA-directed CAR-T cell therapy marketed as Carvykti for relapsed/refractory multiple myeloma. It is a personalized cellular therapy made from each patient's own T cells. The product is approved in the U.S. and EU and is prescription-only.
A phase 2 trial in high-risk smoldering multiple myeloma found all 20 patients treated with cilta-cel became MRD-negative within two months and remained so after 15.3 months. No disease progression, death, dose-limiting toxicities, or high-grade side effects were observed.
A multinational survey shows bridging therapy is used for over 85% of multiple myeloma patients awaiting CAR T-cell therapy, with proteasome inhibitors being the most common approach. Most centers lack standardized protocols and typically bridge patients for 1-2 months, with regimen selection driven primarily by prior therapy history and disease burden.
CAR T-cell therapy is delivering high remission rates for multiple myeloma patients, with improved handoff communication reducing infection risks. FDA-approved BCMA-targeting products show response rates from 72% to 98% in heavily pretreated patients.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07149857 |
A Study to Evaluate Efficacy and Safety of Ciltacabtagene Autoleucel |
RECRUITING | PHASE2 |
| NCT06577025 |
A Study of Different Sequences of Cilta-cel, Talquetamab in Combination With Daratumumab and Teclistamab in Combination With Daratumumab Following Induction With Daratumumab, Bortezomib, Lenalidomide and Dexamethasone in Participants With Standard-risk Newly Diagnosed Multiple Myeloma |
ACTIVE_NOT_RECRUITING | PHASE2 |
| NCT06550895 |
A Study of Ciltacabtagene Autoleucel and Talquetamab for the Treatment of Participants With High-Risk Multiple Myeloma |
ACTIVE_NOT_RECRUITING | PHASE2 |
| NCT05347485 |
A Study of JNJ-68284528 Out-of-Specification (OOS) for Commercial Release in Participants With Multiple Myeloma |
COMPLETED | PHASE2 |
| NCT05257083 |
A Study of Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) Followed by Ciltacabtagene Autoleucel Versus Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) Followed by Autologous Stem Cell Transplant (ASCT) in Participants With Newly Diagnosed Multiple Myeloma |
ACTIVE_NOT_RECRUITING | PHASE3 |
| NCT05201781 |
A Long-term Study for Participants Previously Treated With Ciltacabtagene Autoleucel |
RECRUITING | PHASE4 |
| NCT04923893 |
A Study of Bortezomib, Lenalidomide and Dexamethasone (VRd) Followed by Cilta-cel, a CAR-T Therapy Directed Against BCMA Versus VRd Followed by Lenalidomide and Dexamethasone (Rd) Therapy in Participants With Newly Diagnosed Multiple Myeloma for Whom ASCT is Not Planned as Initial Therapy |
ACTIVE_NOT_RECRUITING | PHASE3 |
| NCT04181827 |
A Study Comparing JNJ-68284528, a CAR-T Therapy Directed Against B-cell Maturation Antigen (BCMA), Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd) in Participants With Relapsed and Lenalidomide-Refractory Multiple Myeloma |
ACTIVE_NOT_RECRUITING | PHASE3 |
