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Bending the Curve Trial by Trial
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TRANSCEND CLL 004

Study Evaluating Safety and Efficacy of JCAR017 in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)

Phase 1/2N = 117NCT03331198

Population
Adults with relapsed or refractory CLL or SLL and at least two previous lines of therapy including a BTK inhibitor; 70 of the 117 treated patients had also experienced venetoclax failure.
Design
Open-label single-arm phase 1-2 study in the USA: one intravenous infusion of liso-cel at one of two target dose levels (50 million or 100 million CAR-positive T cells; dose level 2 is the higher). 137 enrolled patients underwent leukapheresis and 117 received liso-cel. Primary endpoint: complete response or remission, including with incomplete marrow recovery, by independent review (2018 iwCLL criteria) in the primary efficacy analysis set at dose level 2, with a null hypothesis of 5% or less. ClinicalTrials.gov lists 320 as estimated enrolment.
Primary endpoint
CR/CRi rate
Arms
  • Lisocabtagene maraleucel (experimental, n = 117): Single infusion of liso-cel at 50 million (dose level 1) or 100 million (dose level 2) CAR-positive T cells
People
Siddiqi T
Show the numbers
Results reported for TRANSCEND CLL 004
EndpointAnalysisLisocabtagene maraleucelControlEffect
CR/CRi ratePrimary efficacy analysis set at dose level 2: previous BTK inhibitor progression and venetoclax failure (49)Complete response or remission, including with incomplete marrow recovery, by independent review (2018 iwCLL criteria)primarySiddiqi 202318% (9–32%)—P=0.00069 of 49 patients; null hypothesis 5% or less. Independent review, 2018 iwCLL criteria.
Results reported for TRANSCEND CLL 004
EndpointAnalysisLisocabtagene maraleucelControlEffect
CR/CRi ratePrimary efficacy analysis set at dose level 2: previous BTK inhibitor progression and venetoclax failure (49)Complete response or remission, including with incomplete marrow recovery, by independent review (2018 iwCLL criteria)primarySiddiqi 202318% (9–32%)—P=0.00069 of 49 patients; null hypothesis 5% or less. Independent review, 2018 iwCLL criteria.
Primary publication: Siddiqi T, Maloney DG, Kenderian SS, Brander DM, Dorritie K, Soumerai J, et al. Lisocabtagene maraleucel in chronic lymphocytic leukaemia and small lymphocytic lymphoma (TRANSCEND CLL 004): a multicentre, open-label, single-arm, phase 1-2 study. Lancet. 2023;402(10402):641-654. PubMedDOI

Appears in

Sources

  1. Siddiqi T, Maloney DG, Kenderian SS, Brander DM, Dorritie K, Soumerai J, et al. Lisocabtagene maraleucel in chronic lymphocytic leukaemia and small lymphocytic lymphoma (TRANSCEND CLL 004): a multicentre, open-label, single-arm, phase 1-2 study. Lancet. 2023;402(10402):641-654.

    PubMedDOI