Therapy Detail
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| Therapy Name | Lisocabtagene maraleucel |
| Synonyms | |
| Therapy Description |
Breyanzi (lisocabtagene maraleucel) comprises equal amount of CD4+ and CD8+ autologous T lymphocytes engineered to express chimeric antigen receptors containing an anti-CD19 fragment fused to the 4-1BB (CD137) signaling domain, which may results in immune modulating and anti-tumor activities (PMID: 32888407). Breyanzi (lisocabtagene maraleucel) is FDA approved for use in patients with large B-cell lymphoma including diffuse large B-cell lymphoma, high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B, who are refractory to or relapsed within 12 months of first-line immunochemothrapy, or have refractory or relapsed disease after first-line immunochemothrapy and not eligible for r hematopoietic stem cell transplantation, or have relapsed or refractory disease after two or more lines of systemic therapy (FDA.gov). |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Lisocabtagene maraleucel | Breyanzi | JCAR 017|JCAR017|JCAR-017 | Breyanzi (lisocabtagene maraleucel) comprises equal amount of CD4+ and CD8+ autologous T lymphocytes engineered to express chimeric antigen receptors containing an anti-CD19 fragment fused to the 4-1BB (CD137) signaling domain, which may results in immune modulating and anti-tumor activities (PMID: 32888407). Breyanzi (lisocabtagene maraleucel) is FDA approved for use in patients with large B-cell lymphoma including diffuse large B-cell lymphoma, high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B, who are refractory to or relapsed within 12 months of first-line immunochemothrapy, or have refractory or relapsed disease after first-line immunochemothrapy and not eligible for r hematopoietic stem cell transplantation, or have relapsed or refractory disease after two or more lines of systemic therapy (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 |
|---|---|---|---|---|---|---|
| NCT03484702 | Phase II | Lisocabtagene maraleucel | Trial to Determine the Efficacy and Safety of JCAR017 in Adult Subjects With Aggressive B-Cell Non-Hodgkin Lymphoma (TRANSCENDWORLD) | Active, not recruiting | ITA | GBR | FRA | ESP | DEU | BEL | AUT | 4 |
| NCT03483103 | Phase II | Lisocabtagene maraleucel | Lisocabtagene Maraleucel (JCAR017) as Second-Line Therapy (TRANSCEND-PILOT-017006) | Completed | USA | 0 |
| NCT02631044 | Phase I | Lisocabtagene maraleucel | Study Evaluating the Safety and Pharmacokinetics of JCAR017 in B-cell Non-Hodgkin Lymphoma (TRANSCEND-NHL-001) | Active, not recruiting | USA | 0 |
| NCT03331198 | Phase Ib/II | Lisocabtagene maraleucel Ibrutinib + Lisocabtagene maraleucel | Study Evaluating Safety and Efficacy of JCAR017 in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) | Active, not recruiting | USA | 0 |
| NCT04245839 | Phase II | Lisocabtagene maraleucel Cyclophosphamide + Fludarabine | A Study to Evaluate the Efficacy and Safety of JCAR017 in Adult Subjects With Relapsed or Refractory Indolent B-cell Non-Hodgkin Lymphoma (NHL) (TRANSCEND FL) | Active, not recruiting | USA | ITA | GBR | FRA | ESP | DEU | CAN | AUT | 2 |
| NCT03744676 | Phase II | Lisocabtagene maraleucel | A Safety Trial of Lisocabtagene Maraleucel (JCAR017) for Relapsed and Refractory (R/R) B-cell Non-Hodgkin Lymphoma (NHL) in the Outpatient Setting (TRANSCEND-OUTREACH-007) | Active, not recruiting | USA | 0 |
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