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)

Brief description of study

This is a Phase 1/2 study to test how safe different doses of the chimeric antigen receptor (CAR-T) medicine AB-3028 are for adults with metastatic castration-resistant prostate cancer (mCRPC). The study wants to find the highest dose that is safe (maximum tolerated dose, or MTD) or the best dose to use in the next stage of testing (recommended Phase 2 dose, or RP2D). This will be done by giving the medicine either after lymphodepletion (a type of treatment that lowers certain cells in the body) or without this treatment.

The study will be split into different stages. These stages include: screening, leukapheresis, pre-treatment, lymphodepletion, treatment and follow up. The study has two main parts: phase 1(dose finding) and phase 2(dose expansion). In Phase 1, different doses of AB-3028 will be tested to find the highest dose that is safe or the most that can be given. This will help decide on the best dose to use in the next phase. Phase 2 will use the best dose found in Phase 1 and test it on more people to see how well it works and how safe it is. All patients will have frequent medical check ups and blood samples taken to see how their bodies are handling the study medicine. The study team will have special scans done for all patients to see how the cancer is responding to the study medicines. The study team will be monitoring the patients for potential side effects and safety concerns.


Clinical Study Identifier: s25-01304
ClinicalTrials.gov Identifier: NCT07285694
Principal Investigator: Minas Platon Economides.
Other Investigators: Nicole Karich, Rena Kandinova, Laura Catherine Bauer, Jamie M Pavlonnis, Michelle Sun, Marissa Hornacek, Maureen Elizabeth Johnson, Rafael C Singson, Amanda Marie Ferris, Jingmei Hsu, Mohammad Maher Abdul Hay, Samuel Yamshon, David R. Wise, Jacqueline L Ortiz, Kelsey Stocker, Sejal Singh, Laura P. Diaz, Victor Ricardo Adorno Febles, Kristen Randolph Jordan, Jamie Robin Nemrow, Chelsea F Curione, Elizabeth Catherine Garace.


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