A Phase 1 Multicenter Study Evaluating the Safety and Efficacy of ALLO-316 Following ALLO-647 Containing Conditioning Regimen in Subjects with Advanced or Metastatic Clear Cell Renal Cell Carcinoma (ccRCC)
he purpose of the TRAVERSE study is to assess the safety, efficacy, and cell kinetics of ALLO-316 in adults with advanced or metastatic clear cell renal cell carcinoma after a lymphodepletion regimen comprising fludarabine, cyclophosphamide, and ALLO-647 to define a Phase 2 dose.
-to assess safety and tollerability 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 conditioning with fludarabine/cyclophosphamide (Flu/Cy) and ALLO-647 and to select the recommended Phase 2 dose (RP2D) of ALLO-316.
-to assess safety and tolerability of ALLO-647 in combination with Flu/Cy prior to ALLO-316 and to establish the RP2D of ALLO-647.
-to evaluate the overall safety provile of ALLO-316 following ALLO-647 in combination with Flu/Cy.
-to evaluate anti-tumor 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 CD70 expression
-to explore potential biomarker development based on assessment of blood cells and tumor cells for ALLO-316 and ALLO-647
-to explore changes in immunoregulatory transcripts (RNA profile) and T cell clonal diversity (TCR DNA sequencing) and its relationship to ALLO-316 expansion, persistence, and activity
-to explore the impact of ALLO-316 on systemic soluble immune factors
-to collect banked biospecimens for exploratory research, unless prohibited by local regulations or ethics committee decision
-to evaluate host immune cell depletion and reconstitution resulting from condition with ALLO-647 in combination with Flu/Cy prior to ALLO-316
-to describe the preliminary antitumor activity of ALLO-316 in subjects with ccRCC based on immune-related RECIST (irRECIST) criteria
-to explore the safety and efficacy of retreatment with ALLO-316
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