A Phase I/II Open Label Study to Evaluate the Safety, Cellular Kinetics, and Efficacy of AZD0754, aChimeric Antigen Receptor (CAR) T-cell Therapy Directed Against STEAP2, in Adult Participantswith Metastatic Prostate Cancer: APOLLO

Contact:

NCT Number:

Protocol:

AAAV6446

Study Status:

Active/Enrolling

Population:

Adult

Phase:

I/II

The purpose of this study whether AZD0754 is safe to administer to people with prostate cancer that has spread to other parts of your body (metastatic) and whether it can help to treat their type of cancer. AZD0754 is a type of study treatment called chimeric antigen receptor or CAR T-cell therapy. It uses cells from the subject's own immune system, called T-cells, to attack cancer cells. AZD0754 has not been approved by the Food and Drug Administration (FDA). This is a first in human study. A few days before AZD0754 infusion, the subject will have chemotherapy to lower the number of white blood cells in your body. This is called lymphodepleting chemotherapy (LDC). LDC is used to help make it easier for AZD0754 to grow and survive in the body. This study uses LDC therapies such as cyclophosphamide, fludarabine, or bendamustine. The study doctor will determine the best LDC option and duration of study treatment based on the subject's needs.

Are you Eligible? (Inclusion Criteria)

  • Must be 18 years old or older - Must not have prior solid organ transplantation - Must weigh more than 39 kg (86 pounds)

Specialty Area(s)

Prostate Cancer, Cell Therapy, Immunotherapy

Principal Investigator

Trial Location(s)

CUIMC/Herbert Irving Pavilion
161 Fort Washington Avenue
New York, NY 10032