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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04696731
Recruitment Status : Recruiting
First Posted : January 6, 2021
Last Update Posted : March 29, 2022
Information provided by (Responsible Party):
Allogene Therapeutics

Tracking Information
First Submitted Date  ICMJE January 4, 2021
First Posted Date  ICMJE January 6, 2021
Last Update Posted Date March 29, 2022
Actual Study Start Date  ICMJE February 24, 2021
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 4, 2021)
  • Proportion of subjects experiencing Dose Limiting Toxicities at increasing doses of ALLO-316 [ Time Frame: 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of ALLO-316 in Subjects With Advanced or Metastatic Clear Cell Renal Cell Carcinoma
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Advanced/Metastatic Clear Cell Renal Cell Carcinoma
Intervention  ICMJE
  • Genetic: ALLO-316
    ALLO-316 is an allogeneic CAR T cell therapy targeting CD70
  • Biological: ALLO-647
    ALLO-647 is a monoclonal antibody that recognizes a CD52 antigen
  • Drug: Fludarabine
    Chemotherapy for lymphodepletion
  • Drug: Cyclophosphamide
    Chemotherapy for lymphodepletion
Study Arms  ICMJE Experimental: ALLO-647, ALLO-316
  • Genetic: ALLO-316
  • Biological: ALLO-647
  • Drug: Fludarabine
  • Drug: Cyclophosphamide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 9, 2022)
Original Estimated Enrollment  ICMJE
 (submitted: January 4, 2021)
Estimated Study Completion Date  ICMJE October 2025
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Allogene 415-604-5696
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT04696731
Other Study ID Numbers  ICMJE ALLO-316-101
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Allogene Therapeutics
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Allogene Therapeutics
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Allogene Therapeutics
Verification Date March 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP