Safety and Efficacy of ALLO-316 in Subjects With Advanced or Metastatic Clear Cell Renal Cell Carcinoma
- Conditions
- Advanced/Metastatic Clear Cell Renal Cell Carcinoma
- Interventions
- Registration Number
- NCT04696731
- Lead Sponsor
- Allogene Therapeutics
- 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 available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 120
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description ALLO-647, ALLO-316 ALLO-647 - ALLO-647, ALLO-316 ALLO-316 - ALLO-647, ALLO-316 Fludarabine - ALLO-647, ALLO-316 Cyclophosphamide -
- Primary Outcome Measures
Name Time Method Proportion of patients experiencing Dose Limiting Toxicity with ALLO-647 in combination with fludarabine/cyclophosphamide administered prior to ALLO-316 33 days Proportion of subjects experiencing Dose Limiting Toxicities at increasing doses of ALLO-316 28 days
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (10)
UCSF Medical Center
🇺🇸San Francisco, California, United States
Yale School of Medicine
🇺🇸New Haven, Connecticut, United States
Georgetown University Hospital
🇺🇸Washington, District of Columbia, United States
Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
City of Hope
🇺🇸Duarte, California, United States
UCLA Medical Center
🇺🇸Los Angeles, California, United States
Moffitt Cancer Center
🇺🇸Tampa, Florida, United States
Memorial Sloan Kettering Cancer Center
🇺🇸New York, New York, United States
Providence Portland Medical Center
🇺🇸Portland, Oregon, United States
MD Anderson Cancer Center
🇺🇸Houston, Texas, United States