Metastatic Castration Resistant Prostate Cancer (mCRPC)Phase 1/2NCT07285694
AB-3028, a Programmable Circuit T Cell Therapy in Patients With Castration Resistant Prostate Cancer (CRPC)
A Phase 1/2 study testing AB-3028 in people with Metastatic Castration Resistant Prostate Cancer (mCRPC), run by Arsenal Biosciences, Inc. at 9 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Metastatic Castration Resistant Prostate Cancer (mCRPC)
- What is being tested?
- AB-3028
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 9 sitesUnited States
- Study dates
- 9 Jan 2026to May 2031
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
University of Colorado Hospital - Anschutz Inpatient Pavilion (AIP)
Aurora, Colorado, 80045
City of Hope
Duarte, California, 91010
The University of Kansas Cancer Center
Fairway, Kansas, 66205
University of Iowa and Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242
USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033
University of Minnesota
Minneapolis, Minnesota, 55455
Perlmutter Cancer Center - NYU Langone Health
New York, New York, 10016
University of California, San Francisco
San Francisco, California, 94143
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
About this study
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)
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).
Read the 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.
- Being tested
- AB-3028
- Keywords
- prostate cancer, metastatic, Programmable circuit T cell, CRPC, AB-3028, autologous Cell Therapy, Cell Therapy, CAR T, castration resistant
- Medical subject headings
- Prostatic Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AB-3028Biological
autologous T cell therapy
| Study group | Role | What they receive |
|---|---|---|
| AB-3028 | Experimental | Patients receive a single dose of AB-3028 intravenously on day 0. Receives: Biological: AB-3028 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From AB-3028 infusion up to 24 months post-infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2025
- Study start9 Jan 2026
- Primary completionMay 2029 (estimated)
- Study completionMay 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Castration Resistant Prostate Cancer (mCRPC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arsenal Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07285694
- Sponsor's protocol ID
- AB-3028-201
- Status last verified
- Sep 2026
- First submitted
- 10 Dec 2025
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT07285694
- Acronym / sponsor ID
- AB-3028-201
- Keywords
- prostate cancer, metastatic, Programmable circuit T cell, CRPC, AB-3028, autologous Cell Therapy, Cell Therapy, CAR T
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- Arsenal Biosciences, Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Jan 2026 (actual)
- Primary completion
- May 2029 (estimated)
- Study completion
- May 2031 (estimated)
- First posted
- 16 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AB-3028 | Experimental | Biological: AB-3028Patients receive a single dose of AB-3028 intravenously on day 0. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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:
- Prior prostate cancer treatment with at least 1 novel androgen receptor pathway inhibitor (ARPI) therapy.
- Adequate organ functions.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AB-3028autologous T cell therapy | Biological | AB-3028 |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing AB-3028 in people with Metastatic Castration Resistant Prostate Cancer (mCRPC), run by Arsenal Biosciences, Inc. at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability of AB-3028 (time frame: From AB-3028 infusion up to 24 months post-infusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.