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

September 1, 2026 updated by: Arsenal Biosciences, Inc.

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)

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).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

190

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Duarte, California, United States, 91010
        • City of Hope
      • Los Angeles, California, United States, 90033
        • USC Norris Comprehensive Cancer Center
      • San Francisco, California, United States, 94143
        • University of California, San Francisco
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Hospital - Anschutz Inpatient Pavilion (AIP)
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa and Holden Comprehensive Cancer Center
    • Kansas
      • Fairway, Kansas, United States, 66205
        • The University of Kansas Cancer Center
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota
    • New York
      • New York, New York, United States, 10016
        • Perlmutter Cancer Center - NYU Langone Health
    • Washington
      • Seattle, Washington, United States, 98109
        • Fred Hutchinson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AB-3028
Patients receive a single dose of AB-3028 intravenously on day 0.
Biological: AB-3028
autologous T cell therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and tolerability of AB-3028
Time Frame: 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
From AB-3028 infusion up to 24 months post-infusion

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Phase 1 (Dose escalation and Backfill Cohorts): incidence of adverse events
Time Frame: From AB-3028 infusion up to 24 months post-infusion
Defined as dose-limiting toxicities based on a Bayesian optimal interval (BOIN) design
From AB-3028 infusion up to 24 months post-infusion
Phase 2 (Cohort expansion): Objective response rate (ORR)
Time Frame: From AB-3028 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
From AB-3028 infusion up to 24 months post-infusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Arsenal Biosciences, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 9, 2026

Primary Completion (Estimated)

May 1, 2029

Study Completion (Estimated)

May 1, 2031

Study Registration Dates

First Submitted

December 10, 2025

First Submitted That Met QC Criteria

December 10, 2025

First Posted (Actual)

December 16, 2025

Study Record Updates

Last Update Posted (Actual)

September 3, 2026

Last Update Submitted That Met QC Criteria

September 1, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AB-3028-201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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