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 result 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 immunochemotherapy, or have refractory or relapsed disease after first-line immunochemotherapy and not eligible for hematopoietic stem cell transplantation, or have relapsed or refractory disease after two or more lines of systemic therapy, and in patients with relapsed or refractory mantle cell lymphoma who have received at least two prior 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 | CD19 Immune Cell Therapy 62 | 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 result 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 immunochemotherapy, or have refractory or relapsed disease after first-line immunochemotherapy and not eligible for hematopoietic stem cell transplantation, or have relapsed or refractory disease after two or more lines of systemic therapy, and in patients with relapsed or refractory mantle cell lymphoma who have received at least two prior 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) | Completed | NLD | ITA | GBR | FRA | FIN | ESP | DEU | CHE | BEL | AUT | 1 |
| NCT03483103 | Phase II | Lisocabtagene maraleucel | Lisocabtagene Maraleucel (JCAR017) as Second-Line Therapy (TRANSCEND-PILOT-017006) | Completed | USA | 0 |
| 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) | 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) | Completed | 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) | Recruiting | USA | SWE | ITA | GBR | FRA | ESP | DEU | CAN | AUT | 1 |
| NCT06205290 | Phase III | Idelalisib + Rituximab Lisocabtagene maraleucel Cyclophosphamide + Fludarabine Bendamustine + Rituximab | A Study to Compare the Efficacy and Safety of Lisocabtagene Maraleucel vs Investigator's Choice Options in Adult Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma, Whose Disease Has Failed Treatment With Both BTKi and BCL2i Therapies | Withdrawn | USA | SWE | NOR | NLD | ITA | GBR | FRA | ESP | DEU | BEL | AUT | 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) | Recruiting | USA | CAN | 0 |
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