Therapy Detail

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Therapy Name Lisocabtagene maraleucel
Synonyms
Therapy Description

JCAR017 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).

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Lisocabtagene maraleucel Breyanzi 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 relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma, high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B (FDA.gov).

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
Unknown unknown follicular lymphoma not applicable Lisocabtagene maraleucel FDA approved Actionable In a Phase I trial (TRANSCEND NHL 001) that supported FDA approval, Breyanzi (lisocabtagene maraleucel) treatment resulted in an objective response in 73% (186/256, 136 complete responses) of patients with relapsed or refractory large B-cell lymphoma, including follicular lymphoma grade 3B,high-grade B-cell lymphoma, diffuse large B-cell lymphoma, and primary mediastinal B-cell lymphoma (PMID: 32888407; NCT02631044). 32888407 detail...
Unknown unknown primary mediastinal B-cell lymphoma not applicable Lisocabtagene maraleucel FDA approved Actionable In a Phase I trial (TRANSCEND NHL 001) that supported FDA approval, Breyanzi (lisocabtagene maraleucel) treatment resulted in an objective response in 73% (186/256, 136 complete responses) of patients with relapsed or refractory large B-cell lymphoma, including primary mediastinal B-cell lymphoma, high-grade B-cell lymphoma, diffuse large B-cell lymphoma, and follicular lymphoma grade 3B (PMID: 32888407; NCT02631044). 32888407 detail...
Unknown unknown B-cell lymphoma not applicable Lisocabtagene maraleucel FDA approved Actionable In a Phase I trial (TRANSCEND NHL 001) that supported FDA approval, Breyanzi (lisocabtagene maraleucel) treatment resulted in an objective response in 73% (186/256, 136 complete responses) of patients with relapsed or refractory large B-cell lymphoma, including high-grade B-cell lymphoma, diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma, and follicular lymphoma grade 3B (PMID: 32888407; NCT02631044). 32888407 detail...
Unknown unknown diffuse large B-cell lymphoma not applicable Lisocabtagene maraleucel FDA approved Actionable In a Phase I trial (TRANSCEND NHL 001) that supported FDA approval, Breyanzi (lisocabtagene maraleucel) treatment resulted in an objective response in 73% (186/256, 136 complete responses) of patients with relapsed or refractory large B-cell lymphoma, including diffuse large B-cell lymphoma, high-grade B-cell lymphoma, primary mediastinal B-cell lymphoma, and follicular lymphoma grade 3B (PMID: 32888407; NCT02631044). 32888407 detail...
Unknown unknown diffuse large B-cell lymphoma not applicable Lisocabtagene maraleucel Clinical Study Actionable In a clinical case study, treatment with Breyanzi (lisocabtagene maraleucel) resulted in complete remission and durable central nervous system response in a patient with diffuse large B-cell lymphoma (PMID: 28834486). 28834486

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT03483103 Phase II Lisocabtagene maraleucel Lisocabtagene Maraleucel (JCAR017) as Second-Line Therapy (TRANSCEND-PILOT-017006) 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) Recruiting USA | CAN 8
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 0
NCT02631044 Phase I Lisocabtagene maraleucel Study Evaluating the Safety and Pharmacokinetics of JCAR017 in B-cell Non-Hodgkin Lymphoma (TRANSCEND-NHL-001) Recruiting USA 0
NCT03744676 Phase II Lisocabtagene maraleucel A Safety Trial of Lisocabtagene Maraleucel (JCAR017) for Relapsed and Refractory (R/R) B-cell Non-Hodgkin Ldymphoma (NHL) in the Outpatient Setting (TRANSCEND-OUTREACH-007) Recruiting USA 0


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