An Open-label, Multicenter Phase 1/2 Study to Evaluate the Safety and Efficacy of AB-2100 in Patients With Recurrent Advanced or Metastatic Clear-cell Renal Cell Carcinoma (ccRCC)

AB-2100-201

This is a multi-center, open-label phase 1/2 trial evaluating the safety and efficacy of AB-2100 cell product. The study may enroll approximately 60 patients in phase 1 and approximately 70 patients in phase 2.

2024-02-26

2025-02-26

2027-05-31

Recruiting

Early phase I

130

Inclusion Criteria: * Advanced or metastatic clear-cell renal cell carcinoma * Must have received an immune checkpoint inhibitor and a VEGF-targeted therapy in the advanced or metastatic setting. Must have evidence of progression on or after the last treatment regimen or discontinued treatment for unacceptable toxicity. * Adequate organ function as per protocol definitions. * Eastern Cooperative Oncology Group (ECOG) performance status score 0 or 1. * Measurable disease at time of enrollment as per protocol definitions. * Female subjects of childbearing potential and male subjects must agree to use acceptable method(s) of contraception from enrollment through at least 12 months after AB-2100 infusion. Exclusion Criteria: * Any prior systemic RCC therapy within 14 days of time of cell collection (interval of 28 days will be required if the last immediate treatment contained an antibody-based agent). * Systemic anti-cancer therapy within 14 days of starting of conditioning chemotherapy (interval of 28 days will be required if the last immediate treatment contained an antibody-based agent) * Investigational cellular therapies within 8 weeks prior to start of conditioning chemotherapy * Prior treatment with anti-CA9 therapies * Myocardial infarction or unstable angina within 6 months prior to screening * Pleural effusion that requires drainage for symptom management within 28 days of screening. * Active autoimmune disease requiring immunosuppressive therapy or uncontrolled with treatment. * Untreated brain metastasis. * Subjects unwilling to participate in an extended safety monitoring period.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 130, 'type': 'ESTIMATED'}}

2024-03-25