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| Therapy Name | Ciltacabtagene autoleucel |
| Synonyms | |
| Therapy Description |
Carvykti (ciltacabtagene autoleucel) is a chimeric antigen receptor T (CAR T)-cell therapy targeting B-cell maturation antigen (BCMA) that may induce cytotoxic immune response against BCMA-expressing tumor cells (PMID: 31622496, PMID: 34175021). Carvykti (ciltacabtagene autoleucel) is FDA approved for use in adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy (FDA.gov). |
| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Ciltacabtagene autoleucel | Carvykti | JNJ-68284528|JNJ-4528|Cilta-cel | TNFRSF17 Immune Cell Therapy 27 | Carvykti (ciltacabtagene autoleucel) is a chimeric antigen receptor T (CAR T)-cell therapy targeting B-cell maturation antigen (BCMA) that may induce cytotoxic immune response against BCMA-expressing tumor cells (PMID: 31622496, PMID: 34175021). Carvykti (ciltacabtagene autoleucel) is FDA approved for use in adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy (FDA.gov). |
| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|
| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT07149857 | Phase II | Daratumumab + Dexamethasone + Lenalidomide Ciltacabtagene autoleucel Cyclophosphamide Bortezomib + Dexamethasone + Lenalidomide Cyclophosphamide + Fludarabine Bortezomib + Daratumumab + Dexamethasone + Lenalidomide | A Study to Evaluate Efficacy and Safety of Ciltacabtagene Autoleucel (CARTITUDE-10) | Recruiting | USA | ESP | AUS | 0 |
| NCT05347485 | Phase II | Ciltacabtagene autoleucel Cyclophosphamide + Fludarabine | A Study of JNJ-68284528 Out-of-Specification (OOS) for Commercial Release in Participants With Multiple Myeloma | Completed | USA | 0 |
| NCT05201781 | FDA approved | Ciltacabtagene autoleucel | A Long-term Study for Participants Previously Treated With Ciltacabtagene Autoleucel | Recruiting | USA | NLD | ISR | FRA | ESP | BEL | 2 |
| NCT05666700 | Phase I | Ciltacabtagene autoleucel | CAR-T Cell Therapy in RelApsed/Refractory Myeloma With ExtrameduLlary Disease - an in Vivo Imaging and Molecular Monitoring Study (CARAMEL) | Recruiting | AUS | 0 |
| NCT06940297 | Phase II | Cyclophosphamide + Fludarabine Ciltacabtagene autoleucel Dasatinib + Quercetin | Dasatinib and Quercetin With CAR-T Therapy for the Treatment of Patients With Relapsed or Refractory Multiple Myeloma | Recruiting | USA | 0 |
| NCT05346835 | Expanded access | Ciltacabtagene autoleucel | Expanded Access Program (EAP) for Ciltacabtagene Autoleucel (Cilta-Cel) Out-of-Specification (OOS) in Participants With Multiple Myeloma | Available | USA | DEU | 0 |
| NCT06577025 | Phase II | Ciltacabtagene autoleucel Cyclophosphamide + Fludarabine Bortezomib + Daratumumab + Dexamethasone + Lenalidomide Daratumumab + Talquetamab-tgvs Daratumumab + Teclistamab | 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 (aMMbition) | Active, not recruiting | USA | ESP | DEU | BRA | AUS | 0 |
| NCT04133636 | Phase II | Ciltacabtagene autoleucel | A Study of JNJ-68284528, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against B-cell Maturation Antigen (BCMA) in Participants With Multiple Myeloma (CARTITUDE-2) | Recruiting | USA | NLD | ISR | FRA | ESP | DEU | BEL | 1 |
| NCT03548207 | Phase Ib/II | Ciltacabtagene autoleucel | A Study of JNJ-68284528, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against B-Cell Maturation Antigen (BCMA) in Participants With Relapsed or Refractory Multiple Myeloma | Completed | USA | 1 |