Safety and Efficacy of ALLO-316 in Subjects With Advanced or Metastatic Clear Cell Renal Cell Carcinoma

Description

This is a Phase 1 dose escalation study following a 3+3 study design. The 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.

Conditions

Advanced/Metastatic Clear Cell Renal Cell Carcinoma

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Study Overview

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Study Details

Study overview

This is a Phase 1 dose escalation study following a 3+3 study design. The 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.

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

Safety and Efficacy of ALLO-316 in Subjects With Advanced or Metastatic Clear Cell Renal Cell Carcinoma

Condition
Advanced/Metastatic Clear Cell Renal Cell Carcinoma
Intervention / Treatment

-

Contacts and Locations

Duarte

City of Hope, Duarte, California, United States, 91010

Los Angeles

UCLA Medical Center, Los Angeles, California, United States, 90095

San Francisco

UCSF Medical Center, San Francisco, California, United States, 94143

New Haven

Yale School of Medicine, New Haven, Connecticut, United States, 06520

Washington

Georgetown University Hospital, Washington, District of Columbia, United States, 20007

Tampa

Moffitt Cancer Center, Tampa, Florida, United States, 33612

Detroit

Karmanos Cancer Institute, Detroit, Michigan, United States, 48201

New York

Memorial Sloan Kettering Cancer Center, New York, New York, United States, 10065

Portland

Providence Portland Medical Center, Portland, Oregon, United States, 97213

Houston

MD Anderson Cancer Center, Houston, Texas, United States, 77030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Allogene Therapeutics,

Study Record Dates

2025-10