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Clinical Trial 21117

Cancer Type: Genitourinary
Study Type: Treatment
NCT#: NCT04696731

Phase: Phase I
Prinicipal Investigator: Jad Chahoud

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or 1-800-679-0775 Learn More
Overview

Study Title

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)

Summary

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.

Objective

Primary Objectives: -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. Secondary Objectives -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 Exploratory Objectives: -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

Treatments

Therapies

Medications

ALLO-316 (); ALLO-647 ()

Inclusion Criteria

  • Histologically confirmed renal cell carcinoma with a predominant clear cell component
  • Must have received a checkpoint inhibitor and a VEGF inhibitor in the advanced and/or metastatic setting
  • At least one measurable lesion as defined by RECIST version 1.1
  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1
  • Absence of donor (product)-specific anti-HLA antibodies (DSA)
  • Adequate hematological, renal, liver, pulmonary, and cardiac functions

  • Exclusion Criteria

  • Central nervous system (CNS) metastatic disease (unless controlled and stable for at least 4 weeks), leptomeningeal disease, or cord compression
  • Clinically significant CNS dysfunction
  • Any other active malignancy within 3 years prior to enrollment
  • Prior treatment with anti-CD70 therapies
  • Current thyroid disorder (including hyperthyroidism) with the exception of hypothyroidism controlled on stable dose of hormone replacement therapy
  • Prior treatment with anti-CD52 monoclonal antibody in the past 12 months
  • Patients unwilling to participate in the extended safety monitoring period

  • If you are interested in learning more about clinical trials, our clinical trial navigators can discuss your options and recommend opportunities that may be suitable for you. Call 813-745-6100 or 1-800-679-0775 (toll-free) or submit a clinical trials inquiry form.

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