Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2025-12-26 @ 2:35 AM
Study NCT ID:
NCT07285694
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-16
First Post:
2025-12-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
AB-3028, a Programmable Circuit T Cell Therapy in Patients With Castration Resistant Prostate Cancer (CRPC)
Sponsor:
Arsenal Biosciences, Inc.
Organization:
Study Overview
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)
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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).
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: