Therapy Detail
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| Therapy Name | Brexucabtagene autoleucel + Cyclophosphamide + Fludarabine |
| Synonyms | |
| Therapy Description | |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Brexucabtagene autoleucel | Tecartus | KTE-X19|KTEX19|KTE X19 | Tecartus (brexucabtagene autoleucel) are autologous T-cells engineered to express an anti-CD-19 chimeric antigen receptor (CAR), which may potentially target CD-19-expressing tumor cells (PMID: 32242358). Tecartus (brexucabtagene autoleucel) is FDA approved for use in adult patients with relapsed or refractory mantle cell lymphoma and patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (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 |
|---|---|---|---|---|---|---|
| NCT05495464 | Phase I | Cyclophosphamide + Fludarabine Brexucabtagene autoleucel + Cyclophosphamide + Fludarabine Acalabrutinib + Rituximab | A Pilot "Window-3" Study of Acalabrutinib Plus Rituximab Followed by Brexucabtagene Autoleucel Therapy in Patients With Previously Untreated High-risk Mantle Cell Lymphoma | Recruiting | USA | 0 |
| NCT04162756 | Expanded access | Brexucabtagene autoleucel + Cyclophosphamide + Fludarabine | Study of KTE-X19 for the Treatment of Individuals With Relapsed/Refractory B-Cell Malignancies (ZUMA-18) | Approved for marketing | USA | 0 |
| NCT04880434 | Phase II | Brexucabtagene autoleucel + Cyclophosphamide + Fludarabine | Study to Evaluate the Efficacy of Brexucabtagene Autoleucel (KTE-X19) in Participants With Relapsed/Refractory Mantle Cell Lymphoma (Cohort 3) (ZUMA-2) | Active, not recruiting | USA | NLD | GBR | FRA | ESP | DEU | 0 |
| NCT05537766 | Phase II | Brexucabtagene autoleucel + Cyclophosphamide + Fludarabine | Study of Brexucabtagene Autoleucel in Adults With Rare B-cell Malignancies (ZUMA-25) | Active, not recruiting | USA | NLD | ITA | FRA | ESP | DEU | CHE | AUT | 0 |
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