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Active, not recruiting Phase 1/2

AB-3028, a Programmable Circuit T Cell Therapy in Patients With Castration Resistant Prostate Cancer (CRPC)

NCT07285694 · tracked via the Priya Life Science USA tracker
Sponsor
Arsenal Biosciences, Inc
Phase
Phase 1/2
Started
2026-01-09
Last updated
2026-09-03

Condition(s) studied

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)

FacilityCityRegionStatus
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 Iowa City Iowa
The University of Kansas Cancer Center Fairway Kansas
University of Minnesota Minneapolis Minnesota
Perlmutter Cancer Center - NYU Langone Health New York New York
Fred Hutchinson Cancer Center Seattle Washington
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 NCT07285694 on ClinicalTrials.gov ↗ ← All trials in the USA