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

Prior treatment

• 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).
• 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

Other illness

• 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)
• Active autoimmune disease requiring immunosuppressive therapy or uncontrolled with treatment.

Other

• Pleural effusion that requires drainage for symptom management within 28 days of screening.
• Untreated brain metastasis.
• Subjects unwilling to participate in an extended safety monitoring period.

• 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.