Therapy Detail
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| Therapy Name | Ciltacabtagene autoleucel + Cyclophosphamide + Fludarabine |
| Synonyms | |
| Therapy Description | |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Ciltacabtagene autoleucel | Carvykti | JNJ-68284528|JNJ-4528|Cilta-cel | 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). | |
| Cyclophosphamide | Cytoxan | CPM | Chemotherapy - Alkylating 18 | Cytoxan (cyclophosphamide) is an alkylating agent, which inhibits DNA replication (NCI Drug Dictionary). Cytoxan (cyclophosphamide) is FDA approved in multiple hematological malignancies, breast cancer, neuroblastoma, ovarian cancer, and retinoblastoma (NCI Drug Dictionary). |
| Fludarabine | Fludara | FAMP|Fludarabine phosphate | Flurdara (fludarabine) is converted to 2-fluoro-ara-ATP intracellularly, which potentially inhibits DNA polymerase alpha, ribonucleotide reductase and DNA primase, leading to decreased DNA synthesis and reduced tumor growth (NCI Drug Dictionary) |
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| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT04923893 | Phase III | Dexamethasone + Lenalidomide Ciltacabtagene autoleucel + Cyclophosphamide + Fludarabine Bortezomib + Dexamethasone + Lenalidomide | 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 (CARTITUDE-5) | Active, not recruiting | USA | SWE | POL | NOR | NLD | ISR | IRL | HUN | GRC | GBR | FRA | FIN | ESP | DNK | DEU | CZE | CHE | CAN | BRA | BEL | AUT | AUS | ARG | 3 |
| NCT05257083 | Phase III | Ciltacabtagene autoleucel + Cyclophosphamide + Fludarabine Bortezomib + Daratumumab + Dexamethasone + Lenalidomide | 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 (CARTITUDE-6) | Recruiting | USA | SWE | NOR | NLD | ITA | ISR | GRC | GBR | FRA | ESP | DEU | CZE | CHE | CAN | BEL | AUS | 1 |
| NCT05767359 | Phase II | Ciltacabtagene autoleucel + Cyclophosphamide + Fludarabine | CAR- PRISM (PRecision Intervention Smoldering Myeloma) | Recruiting | USA | 0 |
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