A Phase 1 Open-Label, Multi-Center Study of PSMA Targeted Genetically Modified Chimeric Antigen Receptor T Cells in Patients with Metastatic Castration Resistant Prostate Cancer
A Study of PSMA Targeted Genetically Modified Chimeric Antigen Receptor T Cells in Patients with Prostate Cancer
Sponsor: Tmunity Therapeutics, Inc.
Enrolling: Male Patients Only
IRB Number: AAAS6101
Contact: Research Nurse Navigator: 212-342-5162 / cancerclinicaltrials@cumc.columbia.edu
Additional Study Information: This research study is investigating a new treatment for cancer that uses your immune system (a type of white blood cell called T cells or T lymphocytes) to try to attack your cancerous cells. T cells fight infections, and may attack cancer cells, in some cases. Currently, your T cells may not able to attack your cancerous cells. The use of these modified T cells (called CART-PSMA cells) is experimental and this is an early research study (or clinical trial) in which the CART-PSMA-TGFDN cells are being tested in humans. An early research study means that only a few people have been treated with CART-PSMA-TGFDN modified T cells. Currently, we do not know the best and safest dose of CART-PSMA-TGFDN cells. The goal of this research study is to find a safe dose in people with advanced prostate cancer, which has spread beyond the prostate and is not responding to hormone therapies. This will be done by using different planned doses of the CART-PSMA-TGFDN cells in small groups of participants, also called a cohort, in this research study. Your study physician will be able to tell you to which cohort you may be assigned. There will be 5 cohorts in this study, and based on how the patients tolerate the infusion of CART-PSMA-TGFDN, other doses may be explored. There will be about 18 people taking part in this study.
This study is closed
Investigator
Mark Stein, MD
Do You Qualify?
Are you at least 18 years of age? Yes No
Do you have metastatic castration resistant prostate cancer? Yes No
Are you able to perform everyday tasks independently? Yes No
Have you had at least 2 prior lines of systemic therapy for your prostate cancer? Yes No
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For more information, please contact:
Research Nurse Navigator
cancerclinicaltrials@cumc.columbia.edu
212-342-5162