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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Phase 1 (Dose escalation): incidence of adverse events — From AB-2100 infusion up to 21 days post infusion Defined as dose-limiting toxicities based on a 3+3 dose escalation study design
Phase 2 (Cohort expansion): Objective response rate (ORR) — From AB-2100 infusion up to 24 months post-infusion ORR based on Independent Review Committee (IRC) assessment, defined as the proportion of subjects who have achieved a best overall response of CR or PR according to RECIST v1.1
Trial sites (9)
Facility
City
Region
Status
Mayo Clinic Hospital
Phoenix
Arizona
City of Hope
Duarte
California
Moffitt Cancer Center
Tampa
Florida
University of Iowa and Holden Comprehensive Cancer Center
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.