Metastatic Castration Resistant Prostate Cancer (mCRPC)
Investigational drug(s) / intervention(s)
AB-3028
AB-3028: autologous T cell therapy
Study summary
This is a multi-center, open-label Phase 1/2 trial evaluating the safety and efficacy of AB-3028 in subjects with metastatic castration resistant prostate cancer (mCRPC).
Eligibility
Sex
MALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Key Inclusion Criteria:
1. At least 18 years of age at time of signing informed consent form.
2. Histologically confirmed adenocarcinoma of the prostate, meeting all of the following criteria:
• Documented progressive metastatic castration-resistant prostate cancer (mCRPC) based on PCWG3 criteria.
3. Prior prostate cancer treatment with at least 1 novel androgen receptor pathway inhibitor (ARPI) therapy.
• PSMA+ by PSMA PET.
* Measurable disease by RECIST 1.1 criteria, or evaluable disease via measurable PSA (≥ 1 ng/mL) per PCWG3 criteria.
4. Adequate organ functions.
Key Exclusion Criteria:
1. Any prior systemic therapy for CRPC within 14 days prior to scheduled protocol required leukapheresis.
2. Central nervous system (CNS) metastatic disease, leptomeningeal disease, or cord compression.
3. Unwillingness to participate in an extended safety monitoring period.
Primary outcome measure(s)
Safety and tolerability of AB-3028 — From AB-3028 infusion up to 24 months post-infusion To assess safety and tolerability of increasing dose levels of AB-3028 in successive cohorts of subjects with metastatic CRPC to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of AB-3028
Trial sites (9)
Facility
City
Region
Status
City of Hope
Duarte
California
USC Norris Comprehensive Cancer Center
Los Angeles
California
University of California, San Francisco
San Francisco
California
University of Colorado Hospital - Anschutz Inpatient Pavilion (AIP)
Aurora
Colorado
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.
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