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Bending the Curve Trial by Trial
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TRANSCEND NHL 001

A Phase 1, Multicenter, Open-Label Study of JCAR017, CD19-targeted Chimeric Antigen Receptor (CAR) T Cells, for Relapsed and Refractory (R/R) B-cell Non-Hodgkin Lymphoma (NHL)

Phase 1N = 269NCT02631044

Population
Adults with relapsed or refractory large B-cell lymphomas (diffuse large B-cell lymphoma, high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangement, transformed indolent lymphoma, primary mediastinal B-cell lymphoma, follicular lymphoma grade 3B); median of three previous lines of therapy.
Design
Seamless-design study at 14 US cancer centres. 344 patients underwent leukapheresis and 269 received at least one dose of lisocabtagene maraleucel (liso-cel) at one of three sequentially tested target dose levels; the recommended target dose was 100 million CAR-positive T cells. Primary endpoints: adverse events, dose-limiting toxicities and objective response rate (Lugano criteria) by independent review committee in the efficacy-evaluable set (256 patients with confirmed PET-positive disease who received at least one dose).
Primary endpoint
ORR
Arms
  • Lisocabtagene maraleucel (experimental, n = 269): Autologous CD19-directed CAR T cells given as sequential CD8-positive and CD4-positive component infusions at equal target doses
People
Abramson JS, senior author Siddiqi T
Show the numbers
Results reported for TRANSCEND NHL 001
EndpointAnalysisLisocabtagene maraleucelControlEffect
ORREfficacy-evaluable set (256 patients)Objective response per Lugano criteria by independent review committee (stated primary endpoint).primaryAbramson 202073% (66.8–78.0%)—186 of 256 patients had an objective response.
CR rateEfficacy-evaluable set (256 patients)primaryAbramson 202053% (46.8–59.4%)—136 of 256 patients had a complete response.
Results reported for TRANSCEND NHL 001
EndpointAnalysisLisocabtagene maraleucelControlEffect
ORREfficacy-evaluable set (256 patients)Objective response per Lugano criteria by independent review committee (stated primary endpoint).primaryAbramson 202073% (66.8–78.0%)—186 of 256 patients had an objective response.
CR rateEfficacy-evaluable set (256 patients)primaryAbramson 202053% (46.8–59.4%)—136 of 256 patients had a complete response.
Primary publication: Abramson JS, Palomba ML, Gordon LI, Lunning MA, Wang M, Arnason J, et al. Lisocabtagene maraleucel for patients with relapsed or refractory large B-cell lymphomas (TRANSCEND NHL 001): a multicentre seamless design study. Lancet. 2020;396(10254):839-852. PubMedDOI

Appears in

Sources

  1. Abramson JS, Palomba ML, Gordon LI, Lunning MA, Wang M, Arnason J, et al. Lisocabtagene maraleucel for patients with relapsed or refractory large B-cell lymphomas (TRANSCEND NHL 001): a multicentre seamless design study. Lancet. 2020;396(10254):839-852.

    PubMedDOI