A Phase I Study of P-PSMA-101 CAR T-Cell Therapy in Men with Metastatic Castration-Resistant Prostate Cancer

Share
Print

Full Title

A Phase 1 Dose Escalation and Expanded Cohort Study of P-PSMA-101 in Subjects with Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Purpose

Prostate cancers initially need the male hormone testosterone for growth. Hormone therapies that lower the level of testosterone are among the most effective treatments for prostate cancers that have spread to other organs (metastasized). The benefits of hormone treatments do not last, however. Over time, many prostate cancers continue to grow despite hormonal therapies; these are called “castration-resistant prostate cancers” (CRPC).

The purpose of this study is to find the best dose of the investigational treatment P-PSMA-101 that can be given safely in men with metastatic CRPC. P-PSMA-101 is a type of immunotherapy called CAR T-cell therapy. Researchers collect some of a patient’s immune cells (white blood cells or lymphocytes called T cells) and send them to a laboratory. These cells are grown to increase their numbers and are then modified to recognize prostate cancer cells that express a protein on their surfaces called prostate-specific membrane antigen (PSMA). These altered immune cells become the P-PSMA-101 treatment. When they are returned to the patient, the new T cells are able to recognize and kill prostate cancer cells containing PSMA.

Participants in this study will receive one or more doses of P-PSMA-101, either alone or with an anticancer drug called rituximab. The treatments are given intravenously (by vein).

Eligibility

Eligibility:

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have metastatic CRPC that continues to grow despite prior treatments for advanced prostate cancer.
  • Patients should recover from the serious side effects of previous treatments. Prior gene therapy or cellular therapy is not permitted.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self-care, and capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for men age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Susan F. Slovin at 646-422-4470.

Protocol

20-278

Phase

I

Disease Status

Relapsed or Refractory

Investigator