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)

ENROLLING
Protocol # :
24-305
Conditions
Advanced/Metastatic Clear Cell Renal Cell Carcinoma
Recurrence
Phase
I/II
Disease Sites
Kidney
Principal Investigator
Xu, Wenxin

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.

24-305