Therapy Detail
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| Therapy Name | axicabtagene ciloleucel |
| Synonyms | |
| Therapy Description |
Yescarta (axicabtagene ciloleucel) is an immunotherapy consisted of peripheral T-lymphocytes engineered to express a chimeric antigen receptor targeting CD19, CD28 and CD3zeta, resulting in immunostimulating and antineoplastic activities (PMID: 32401634). Yescarta (axicabtagene ciloleucel) is FDA approved for adult patients with large B-cell lymphoma who is refractory or relapsed on first-line chemoimmunotherapy or have received two or more lines of therapies, including diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma, and for adult patients with relapsed or refractory follicular lymphoma who have received two or more lines of therapies, but is not indicated for patients with primary central nervous system lymphoma (FDA.gov). |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| axicabtagene ciloleucel | Yescarta | KTE-C19 CAR|KTE-C19 | CD19 Immune Cell Therapy 62 | Yescarta (axicabtagene ciloleucel) is an immunotherapy consisted of peripheral T-lymphocytes engineered to express a chimeric antigen receptor targeting CD19, CD28 and CD3zeta, resulting in immunostimulating and antineoplastic activities (PMID: 32401634). Yescarta (axicabtagene ciloleucel) is FDA approved for adult patients with large B-cell lymphoma who is refractory or relapsed on first-line chemoimmunotherapy or have received two or more lines of therapies, including diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma, and for adult patients with relapsed or refractory follicular lymphoma who have received two or more lines of therapies, but is not indicated for patients with primary central nervous system lymphoma (FDA.gov). |
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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 |
|---|---|---|---|---|---|---|
| NCT05041309 | Phase II | KITE-585 KITE-222 Brexucabtagene autoleucel KITE-718 axicabtagene ciloleucel KITE-439 | Long-term Follow-up Study for Participants of Kite-Sponsored Interventional Studies Treated With Gene-Modified Cells | Enrolling by invitation | USA | NLD | ISR | GBR | FRA | DEU | CAN | AUS | 1 |
| NCT04531046 | Phase II | axicabtagene ciloleucel | Axi-Cel as a 2nd Line Therapy in Patients With Relapsed/Refractory Aggressive B Lymphoma Ineligible to Autologous Stem Cell Transplantation | Active, not recruiting | FRA | BEL | 0 |
| NCT03391466 | Phase III | axicabtagene ciloleucel | A Study Evaluating the Efficacy of Axicabtagene Ciloleucel Compared to Standard of Care Therapy in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma (ZUMA-7) | Active, not recruiting | USA | SWE | NLD | ITA | ISR | GBR | FRA | ESP | DEU | CHE | CAN | BEL | AUT | AUS | 0 |
| NCT03105336 | Phase II | axicabtagene ciloleucel | A Phase 2 Multicenter Study of Axicabtagene Ciloleucel in Subjects With Relapsed/Refractory Indolent Non-Hodgkin Lymphoma (ZUMA-5) | Active, not recruiting | USA | FRA | 0 |
| NCT05077527 | Phase I | axicabtagene ciloleucel Cyclophosphamide + Fludarabine | Immune Cell Therapy (CAR-T) for the Treatment of Patients With HIV and B-Cell Non-Hodgkin Lymphoma | Recruiting | USA | 0 |
| NCT06043323 | Phase II | axicabtagene ciloleucel Cyclophosphamide + Fludarabine | A Phase II Study of Axicabtagene Ciloleucel, an Anti-CD19 Chimeric Antigen Receptor (CAR) Tcell Therapy, in Combination With Radiotherapy (RT) in Relapsed/Refractory Follicular Lymphoma | Recruiting | USA | 0 |
| NCT02348216 | Phase Ib/II | axicabtagene ciloleucel | A Phase 1-2 Multi-Center Study Evaluating KTE-C19 in Subjects With Refractory Aggressive Non-Hodgkin Lymphoma (ZUMA-1) | Completed | USA | NLD | ISR | FRA | DEU | CAN | 0 |
| NCT05794958 | Phase I | axicabtagene ciloleucel | Evaluate Safety of Axicabtagene Ciloleucel Reinfusion (Axi-Cel-2) in Patients With Relapsed and/or Refractory Second Line High-Risk Non-Hodgkin Lymphoma After Standard of Care Axi-Cel | Recruiting | USA | 0 |
| NCT02614066 | Phase Ib/II | axicabtagene ciloleucel | A Study Evaluating KTE-C19 in Adult Subjects With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (r/r ALL) (ZUMA-3) (ZUMA-3) | Completed | USA | NLD | FRA | DEU | CAN | 0 |
| NCT06218602 | Phase II | Fecal microbiota axicabtagene ciloleucel | Pilot Trial of Fecal Microbiota Transplantation for Lymphoma Patients Receiving Axicabtagene Ciloleucel Therapy. | Recruiting | USA | 0 |
| NCT04608487 | Phase I | Cyclophosphamide + Fludarabine axicabtagene ciloleucel | Axi-cel in CNS Lymphoma | Active, not recruiting | USA | 0 |
| NCT05641428 | Phase II | axicabtagene ciloleucel ARI-0001 | Comparison of Point-of-care Produced CAR T-cell With Commercial CAR T-cells in Patients With R/R LBCL (HOVON161) | Recruiting | NLD | 0 |
| NCT02625480 | Phase Ib/II | axicabtagene ciloleucel | A Multi-Center Study Evaluating KTE-C19 in Pediatric and Adolescent Subjects With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (ZUMA-4) | Active, not recruiting | USA | SWE | POL | NLD | ITA | FRA | ESP | DEU | CZE | CAN | BEL | 0 |
| NCT03624036 | Phase Ib/II | Cyclophosphamide + Fludarabine axicabtagene ciloleucel | Safety and Efficacy of KTE-C19 in Adults With Relapsed/Refractory Chronic Lymphocytic Leukemia (ZUMA-8) | Terminated | USA | ITA | 0 |
| NCT05371093 | Phase III | axicabtagene ciloleucel Cyclophosphamide + Doxorubicin + Prednisone + Rituximab + Vincristine Sulfate Cyclophosphamide + Fludarabine Bendamustine + Rituximab Lenalidomide + Rituximab | Study of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Participants With Relapsed/Refractory Follicular Lymphoma (ZUMA-22) | Recruiting | USA | ITA | GBR | FRA | ESP | DEU | 1 |
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