NCT07285694

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
190

participants targeted

Target at P75+ for phase_1

Timeline
61mo left

Started Jan 2026

Longer than P75 for phase_1

Geographic Reach
1 country

6 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress6%
Jan 2026May 2031

First Submitted

Initial submission to the registry

December 10, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 16, 2025

Completed
24 days until next milestone

Study Start

First participant enrolled

January 9, 2026

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2029

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2031

Last Updated

May 5, 2026

Status Verified

April 1, 2026

Enrollment Period

3.3 years

First QC Date

December 10, 2025

Last Update Submit

April 29, 2026

Conditions

Metastatic Castration Resistant Prostate Cancer (mCRPC)

Keywords

prostate cancermetastaticProgrammable circuit T cellCRPCAB-3028autologous Cell TherapyCell TherapyCAR Tcastration resistant

Outcome Measures

Primary Outcomes (1)

  • Safety and tolerability of AB-3028

    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 Outcomes (2)

  • Phase 1 (Dose escalation and Backfill Cohorts): incidence of adverse events

    From AB-3028 infusion up to 24 months post-infusion

  • Phase 2 (Cohort expansion): Objective response rate (ORR)

    From AB-3028 infusion up to 24 months post-infusion

Study Arms (1)

AB-3028

EXPERIMENTAL

Patients receive a single dose of AB-3028 intravenously on day 0.

Biological: AB-3028

Interventions

AB-3028BIOLOGICAL

autologous T cell therapy

AB-3028

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

City of Hope

Duarte, California, 91010, United States

RECRUITING

USC Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

RECRUITING

University of California, San Francisco

San Francisco, California, 94143, United States

RECRUITING

University of Iowa and Holden Comprehensive Cancer Center

Iowa City, Iowa, 52242, United States

RECRUITING

University of Minnesota

Minneapolis, Minnesota, 55455, United States

RECRUITING

Perlmutter Cancer Center - NYU Langone Health

New York, New York, 10016, United States

RECRUITING

MeSH Terms

Conditions

Prostatic NeoplasmsNeoplasm Metastasis

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Arsenal Biosciences, Inc.

CONTACT

650-446-4874clinicaltrials@arsenalbio.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 10, 2025

First Posted

December 16, 2025

Study Start

January 9, 2026

Primary Completion (Estimated)

May 1, 2029

Study Completion (Estimated)

May 1, 2031

Last Updated

May 5, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(6)