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Recruiting Phase 1, Phase 2 NCT07285694

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

Trial Parameters

Condition Metastatic Castration Resistant Prostate Cancer (mCRPC)
Sponsor Arsenal Biosciences, Inc.
Study Type INTERVENTIONAL
Phase Phase 1, Phase 2
Enrollment 190
Sex MALE
Min Age 18 Years
Max Age N/A
Start Date 2026-01-09
Completion 2029-05
Interventions
AB-3028

Brief 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 Criteria

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.

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