NCT07285694

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

An Open-label, Multicenter Phase 1/2 Study to Evaluate the Safety and Efficacy of AB-3028 in Patients With Castration Resistant Prostate Cancer (CRPC)

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 190 (estimated)
• Sponsor: Arsenal Biosciences, Inc. · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

This study is intended for subjects diagnosed with metastatic castration-resistant prostate cancer (mCRPC) and whose disease progressed after treatment with an androgen receptor pathway inhibitor (ARPI). The purpose of this study is to test the safety and efficacy of AB-3028 cells in subjects with metastatic castration-resistant prostate cancer. This treatment has not been approved by the Food and Drug Administration. The goal of the Phase I portion of this study is to evaluate safety profile of AB-3028 and to determine the maximum tolerated dose or recommended phase 2 dose of AB-3028. The Phase 2 portion of the study will investigate the efficacy of AB-3028. T cells are part of the immune system that protect the body from infection and may help fight cancer. The T cells given in this study will come from the subject and will have a DNA cassette put in them that makes them able to recognize a priming antigen as well as Prostate-Specific Membrane Antigen (PSMA), two proteins found on prostate cancer tumor cells. These logic-gated T cells may help the body's immune system identify and kill cancer cells while sparing normal healthy tissues from toxicity. The AB-3028 cells are given as a single intravenous infusion. After completion of study treatment, subjects are followed with serial measurements of safety, tolerability and response. This is a research study to obtain new information that may help people in the future.

Conditions

• Metastatic Castration Resistant Prostate Cancer (mCRPC)

Interventions

Type	Name	Description
BIOLOGICAL	AB-3028	autologous T cell therapy

Timeline

• Start date: 2026-01-09
• Primary completion: 2029-05-01
• Completion: 2031-05-01
• First posted: 2025-12-16
• Last updated: 2026-03-31

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study