Actively Recruiting
An Open-label, Multicenter Phase 1/2 Study to Evaluate the Safety and Efficacy of AB-3028 in Patients With Castration Resistant Prostate Cancer
Led by Arsenal Biosciences, Inc. · Updated on 2026-06-05
190
Participants Needed
9
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating AB-3028, a programmable circuit T cell therapy, in people with metastatic castration-resistant prostate cancer (mCRPC) whose disease has progressed after treatment with androgen receptor pathway inhibitors. This multi-center, open-label Phase 1/2 trial aims to assess the safety, tolerability, and efficacy of AB-3028. The treatment involves modifying the patient's own T cells to recognize specific proteins found on prostate cancer cells, potentially enabling the immune system to target the cancer while avoiding damage to healthy tissues. Participants receive a single intravenous infusion of AB-3028 cells on day 0. In Phase 1, the study focuses on evaluating safety and determining the maximum tolerated or recommended dose. Phase 2 investigates the treatment's effectiveness. After treatment, subjects enter a follow-up period during which safety, tolerability, and response to therapy are regularly monitored. Throughout the trial, participants undergo serial assessments to track safety and treatment effects for up to 24 months after infusion. These evaluations help researchers understand how well the therapy is tolerated and its impact on cancer. The study is designed to gain new knowledge that may benefit future patients with mCRPC.
CONDITIONS
Brief Title
AB-3028, a Programmable Circuit T Cell Therapy in Patients With Castration Resistant Prostate Cancer (CRPC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 18 years of age at time of signing informed consent form.
- Histologically confirmed adenocarcinoma of the prostate.
- 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.
- Positive 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 will not qualify if you...
- 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.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single day (Day 0)
Participants receive a single intravenous infusion of AB-3028 cells, which are modified T cells designed to target prostate cancer cells.
1 visit (in-person infusion)
Duration - Up to 24 months post-infusion
After treatment, participants are followed to monitor safety, tolerability, and response to therapy over time.
Regular follow-up visits for safety and response monitoring
Trial Site Locations
Total: 9 locations
1
City of Hope
Duarte, California, United States, 91010
Actively Recruiting
2
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Actively Recruiting
3
University of California, San Francisco
San Francisco, California, United States, 94143
Actively Recruiting
4
University of Colorado Hospital - Anschutz Inpatient Pavilion (AIP)
Aurora, Colorado, United States, 80045
Actively Recruiting
5
University of Iowa and Holden Comprehensive Cancer Center
Iowa City, Iowa, United States, 52242
Actively Recruiting
6
The University of Kansas Cancer Center
Fairway, Kansas, United States, 66205
Actively Recruiting
7
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
8
Perlmutter Cancer Center - NYU Langone Health
New York, New York, United States, 10016
Actively Recruiting
9
Fred Hutchinson Cancer Center
Seattle, Washington, United States, 98109
Actively Recruiting
Research Team
A
Arsenal Biosciences, Inc.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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