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Brief Title: Therapeutic Vaccine Plus PD-1 Knockout in Prostate Cancer Treatment
Official Title: Clinical Assessment of a Therapeutic Vaccine in Combination With PD-1 Knockout T Cells in the Treatment of Prostate Cancer
Study ID: NCT03525652
Brief Summary: This study is to evaluate the safety and efficacy of a therapeutic vaccine in combination with PD-1 knockout T cells in the treatment of advanced prostate cancer.
Detailed Description: This is a phase 1/2 clinical study investigating the safety and efficacy of a therapeutic vaccine in combination with PD-1 knockout T cells in the treatment of advanced prostate cancer. The therapeutic vaccine is a customized product involving ex vivo treatment of the patient's peripheral blood mononuclear cells with a recombinant fusion protein (PAP-GM-CSF) to activate the expression of the antigen that would activate the immune function to kill cancer cells. The PD-1 knockout engineered T cells are also prepared using patient's T cells in which PD-1 gene will be knocked out using CRISPR Cas9 technology. The therapeutic vaccine and PD-1 knockout T cells will be infused back to the patient in 3 times with a 2-week interval.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
First Affiliated Hospital of Guangdong Pharmaceutical University, Guangzhou, Guangdong, China
Professor Size Chen, Guangzhou, Guangdong, China
Name: Size Chen, MD, PhD
Affiliation: The First Affiliated Hospital of Guangdong Pharmaceutical University
Role: PRINCIPAL_INVESTIGATOR