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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

Filtering

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT05767359 Phase II Ciltacabtagene autoleucel + Cyclophosphamide + Fludarabine CAR- PRISM (PRecision Intervention Smoldering Myeloma) Recruiting USA 0
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 | NLD | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUS 7
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) Recruiting USA | NLD | GBR | FRA | ESP | DEU | CAN | BEL | AUT | AUS 16


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