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NCT Number: NCT07285694

AB-3028, a Programmable Circuit T Cell Therapy 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).

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Key information

Conditions

Metastatic Castration Resistant Prostate Cancer (mCRPC) Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

City of Hope, Duarte, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • At least 18 years of age at time of signing informed consent form.
  • Histologically confirmed adenocarcinoma of the prostate, meeting all of the following criteria:
  • Documented progressive metastatic castration-resistant prostate cancer (mCRPC) based on PCWG3 criteria.
  • 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.
  • Adequate organ functions.

Key Exclusion Criteria:

  • Any prior systemic therapy for CRPC within 14 days prior to scheduled protocol required leukapheresis.
  • Central nervous system (CNS) metastatic disease, leptomeningeal disease, or cord compression.
  • Unwillingness to participate in an extended safety monitoring period.

Treatment and study plan

AB-3028

Biological

autologous T cell therapy

Primary outcomes

  1. 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

Other outcomes

  1. 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

  2. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Arsenal Biosciences, Inc.

CONTACT

[email protected]

650-446-4874

Sponsors and collaborators

Lead sponsor

Arsenal Biosciences, Inc.

Industry

Registry information

Official study title

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)

Important dates

Study start
2026
Primary completion
2029
Study completion
2031
First posted
Dec 16, 2025
Registry last updated
Jun 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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