AB-2100, an Integrated Circuit T (ICT) Cell Therapy in Patients with Recurrent Clear-cell Renal Cell Carcinoma (ccRCC)

Eligibility 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.
• * 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.