AB-3028-201 STUDY: 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).


Why this Research Matters

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.


Who can Participate

Adult

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. Detailed eligibility criteria is available on ClinicalTrials.gov. These requirements will be discussed with your doctor and/or study representative. ClinicalTrials.gov to learn more about this study.


Study ID

Protocol Number: 26-0014

More information available at ClinicalTrials.gov: NCT07285694


Meet the Team

Image of Principal Investigator

Laura Graham, MD

Principal Investigator