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  • A Phase 1 a/b Multicenter Study Evaluating the Safety and Efficacy of ALLO-316 with Cyclophosphamide/Fludarabine Lymphodepletion alone or including ALLO-647 in Subjects with Advanced or Metastatic Clear Cell Renal Cell Carcinoma (ccRCC)

    Cancer Categories
    • Genitourinary (GU)
    Karmanos Trial ID
    • 2023-070
    NCT ID
    • NCT04696731
    Age Group
    • Adult
    • National
    PhaseClick for Clinical Trial Phase DefinitionPhase I
    Includes initial studies to determine the metabolism and pharmacologic actions of drugs in humans, the side effects associated with increasing doses, and to gain early evidence of effectiveness; may include healthy participants and/or patients.
    • Phase I
    Principal Investigator


    Primary Objectives:

    Phase 1a: Dose Escalation

    • To assess safety and tolerability at increasing dose levels of ALLO-316 in successive cohorts of subjects with advanced or metastatic ccRCC to estimate the maximum tolerated dose (MTD) of ALLO-316 administered following lymphodepletion and to select at least 1 Phase 1b expansion cohort dose regimen of ALLO-316.
    • To assess safety and tolerability of Flu and/or Cy in combination with or without ALLO-647 prior to ALLO-316
    • To assess safety and tolerability of other lymphodepletion regimens administered prior to ALLO-316, which may include cyclophosphamide/ALLO-647 (CA), fludarabine/ALLO-647 (FA), or ALLO-647 alone (A).

    Phase 1b: Dose Expansion

    • To evaluate the safety, tolerability, and preliminary efficacy of ALLO-316 at the Phase 1b expansion cohort dose regimen, determine the recommended phase 2 regimen (RP2R), and evaluate the necessity of assessing CD70 expression in subject selection.

    Secondary Objectives:

    • To evaluate the overall safety profile of ALLO-316 following lymphodepletion including or withholding ALLO-647).
    • To evaluate antitumor activity of ALLO-316.
    • To characterize cellular kinetics of ALLO-316.
    • To characterize the pharmacokinetics of ALLO-647.
    • To evaluate immunogenicity against ALLO-316 and ALLO-647.
    • To evaluate correlation of clinical outcomes with baseline tumor CD70 expression.
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