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

September 22, 2025 updated by: Allogene Therapeutics

A Phase 1A/1B 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)

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, with or without ALLO-647 to define a Phase 2 dose.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Duarte, California, United States, 91010
        • City of Hope
      • Los Angeles, California, United States, 90095
        • UCLA Medical Center
      • San Francisco, California, United States, 94143
        • UCSF Medical Center
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Yale School of Medicine
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20007
        • Georgetown University Hospital
    • Florida
      • Tampa, Florida, United States, 33612
        • Moffitt Cancer Center
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Karmanos Cancer Institute
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center
    • Oregon
      • Portland, Oregon, United States, 97213
        • Providence Portland Medical Center
    • Texas
      • Houston, Texas, United States, 77030
        • MD Anderson Cancer Center

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.

Eligibility Criteria

Ages Eligible for Study

14 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ALLO-647, ALLO-316
Biological: ALLO-647
ALLO-647 is a monoclonal antibody that recognizes a CD52 antigen
Drug: Fludarabine
Chemotherapy for lymphodepletion
Drug: Cyclophosphamide
Chemotherapy for lymphodepletion
Genetic: ALLO-316
ALLO-316 is an allogeneic CAR T cell therapy targeting CD70

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of subjects experiencing Dose Limiting Toxicities at increasing doses of ALLO-316
Time Frame: 28 days
28 days
Proportion of patients experiencing Dose Limiting Toxicity with ALLO-647 in combination with fludarabine/cyclophosphamide administered prior to ALLO-316
Time Frame: 33 days
33 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Allogene Therapeutics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 24, 2021

Primary Completion (Estimated)

October 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

January 4, 2021

First Submitted That Met QC Criteria

January 4, 2021

First Posted (Actual)

January 6, 2021

Study Record Updates

Last Update Posted (Estimated)

September 25, 2025

Last Update Submitted That Met QC Criteria

September 22, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALLO-316-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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