AB-3028, a Programmable Circuit T Cell Therapy in Patients With Castration Resistant Prostate Cancer (CRPC)

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.