RecruitingRecruiting
AB-3028, a Programmable Circuit T Cell Therapy in Patients With Castration Resistant Prostate Cancer (CRPC)
NCT07285694 · Arsenal Biosciences, Inc.
In plain English
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Official 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)
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.
Eligibility criteria
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 design
Enrollment target: 190 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2026-01-09
Estimated completion: 2031-05
Last updated: 2026-06-05
Interventions
Biological: AB-3028
Primary outcomes
- • Safety and tolerability of AB-3028 (From AB-3028 infusion up to 24 months post-infusion)
Sponsor
Arsenal Biosciences, Inc. · industry
Contacts & investigators
ContactArsenal Biosciences, Inc. · contact · clinicaltrials@arsenalbio.com · 650-446-4874
All locations (9)
City of HopeRecruiting
Duarte, California, United States
USC Norris Comprehensive Cancer CenterRecruiting
Los Angeles, California, United States
University of California, San FranciscoRecruiting
San Francisco, California, United States
University of Colorado Hospital - Anschutz Inpatient Pavilion (AIP)Recruiting
Aurora, Colorado, United States
University of Iowa and Holden Comprehensive Cancer CenterRecruiting
Iowa City, Iowa, United States
The University of Kansas Cancer CenterRecruiting
Fairway, Kansas, United States
University of MinnesotaRecruiting
Minneapolis, Minnesota, United States
Perlmutter Cancer Center - NYU Langone HealthRecruiting
New York, New York, United States
Fred Hutchinson Cancer CenterRecruiting
Seattle, Washington, United States