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)
Trial Description
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.
Eligibility Requirements
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.