Safety and Efficacy of ALLO-316 in Subjects With Advanced or Metastatic Clear Cell Renal Cell Carcinoma
TRAVERSE
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)
1 other identifier
interventional
120
1 country
10
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, with or without ALLO-647 to define a Phase 2 dose.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Feb 2021
Longer than P75 for phase_1
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 4, 2021
CompletedFirst Posted
Study publicly available on registry
January 6, 2021
CompletedStudy Start
First participant enrolled
February 24, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2025
CompletedSeptember 25, 2025
September 1, 2025
4.6 years
January 4, 2021
September 22, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Proportion of subjects experiencing Dose Limiting Toxicities at increasing doses of ALLO-316
28 days
Proportion of patients experiencing Dose Limiting Toxicity with ALLO-647 in combination with fludarabine/cyclophosphamide administered prior to ALLO-316
33 days
Study Arms (1)
ALLO-647, ALLO-316
EXPERIMENTALInterventions
ALLO-647 is a monoclonal antibody that recognizes a CD52 antigen
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
City of Hope
Duarte, California, 91010, United States
UCLA Medical Center
Los Angeles, California, 90095, United States
UCSF Medical Center
San Francisco, California, 94143, United States
Yale School of Medicine
New Haven, Connecticut, 06520, United States
Georgetown University Hospital
Washington D.C., District of Columbia, 20007, United States
Moffitt Cancer Center
Tampa, Florida, 33612, United States
Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Providence Portland Medical Center
Portland, Oregon, 97213, United States
MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Publications (2)
Namdari H, Rezaei F, Heidarnejad F, Yaghoubzad-Maleki M, Karamigolbaghi M. Immunoinformatics Approach to Design a Chimeric CD70-Peptide Vaccine against Renal Cell Carcinoma. J Immunol Res. 2024 Jan 27;2024:2875635. doi: 10.1155/2024/2875635. eCollection 2024.
PMID: 38314087DERIVEDDewulf J, Flieswasser T, Delahaye T, Vangestel C, Miranda A, de Haard H, Jacobs J, Smits E, Van den Wyngaert T, Elvas F. Site-specific 68Ga-labeled nanobody for PET imaging of CD70 expression in preclinical tumor models. EJNMMI Radiopharm Chem. 2023 Apr 24;8(1):8. doi: 10.1186/s41181-023-00194-3.
PMID: 37093350DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 4, 2021
First Posted
January 6, 2021
Study Start
February 24, 2021
Primary Completion
October 1, 2025
Study Completion
December 1, 2025
Last Updated
September 25, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share