Disease: Prostate Cancer, (NCT03525652)

Disease info:

Prostate cancer is cancer that occurs in the prostate. The prostate is a small walnut-shaped gland in males that produces the seminal fluid that nourishes and transports sperm. Prostate cancer is one of the most common types of cancer. Many prostate cancers grow slowly and are confined to the prostate gland, where they may not cause serious harm. However, while some types of prostate cancer grow slowly and may need minimal or even no treatment, other types are aggressive and can spread quickly.

Prostate cancer may cause no signs or symptoms in its early stages. Advanced prostate cancer may lead to various symptoms, including:

  • Trouble urinating
  • Decreased force in the stream of urine
  • Blood in the urine
  • Blood in the semen
  • Bone pain
  • Losing weight without trying
  • Erectile dysfunction

Prostate cancer that is detected early — when it's still confined to the prostate gland — has the best chance for successful treatment.

The American Cancer Society’s estimates for prostate cancer in the United States for 2021 are: About 248,530 new cases of prostate cancer. About 34,130 deaths from prostate cancer. About 6 cases in 10 are diagnosed in men who are 65 or older.
Official title:
Clinical Assessment of a Therapeutic Vaccine in Combination With PD-1 Knockout T Cells in the Treatment of Prostate Cancer

Principal Investigator: Size Chen, MD, PhD.  The First Affiliated Hospital of Guangdong Pharmaceutical University


China, Guangdong

Study start:
Feb. 28, 2018
30 participants
Gene editing method:
Type of edit:
Gene knock out
Programmed Cell Death 1 (PD-1)
Delivery method:
IND Enabling Pre-clinical
Phase I Safety
Phase II Safety and Dosing
Phase III Safety and Efficacy

Status: Active recruiting


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 customised 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 T cells in which the 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 a total of three times within a 2-week interval.

Last updated: Apr. 21, 2021
Source: US National Institutes of Health (NIH)
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