Clinical Trials in the USA / NCT06245915
Active, not recruiting
Phase 1/2
AB-2100, an Integrated Circuit T Cell Therapy in Patients With Recurrent Clear-cell Renal Cell Carcinoma (ccRCC)
NCT06245915 · tracked via the Priya Life Science USA tracker
Condition(s) studied
Advanced/Metastatic Clear Cell Renal Cell CarcinomaRecurrence
Investigational drug(s) / intervention(s)
AB-2100
AB-2100: autologous T cell therapy
Study summary
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
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 | Iowa City | Iowa | |
| Dana Farber Cancer Institue | Boston | Massachusetts | |
| Perlmutter Cancer Center - NYU Langone Health | New York | New York | |
| Memorial Sloan Kettering Cancer Center | New York | New York | |
| MD Anderson Cancer Center | Houston | Texas | |
| Huntsman Cancer Institute - Univ of Utah Health | Salt Lake City | Utah |
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Official registry record
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.
View NCT06245915 on ClinicalTrials.gov ↗ ← All trials in the USA