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Safety and Efficacy of ALLO-316 in Subjects With Advanced or Metastatic Clear Cell Renal Cell Carcinoma
About
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.
Primary Purpose
Study Type
Phase
Eligibility
Gender
Healthy Volunteers
Minimum Age
Maximum Age
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.
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Study Stats
Protocol No.
21-000495
Category
Kidney Cancer
Principal Investigator
Contact
Location
- UCLA Westwood