Prostate Cancer Vaccines

Launched by SHENZHEN GENO-IMMUNE MEDICAL INSTITUTE · Jul 6, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new type of vaccine designed to help the immune system fight prostate cancer. Unlike some vaccines that target just one part of the cancer, this one uses several targets to train the body's defense cells, called dendritic cells, to recognize and attack cancer cells more effectively. The main goal is to see if this vaccine is safe and whether it might help treat prostate cancer.

Men with confirmed prostate cancer who are generally in good health may be eligible to join the study. Key requirements include having a certain level of blood counts, kidney and liver function within safe limits, and no serious infections or other recent cancers. Participants will need to provide blood samples and undergo a procedure called leukapheresis, which collects specific immune cells to create the vaccine. The study is currently recruiting and focuses on men who meet these criteria and are willing to take part in this innovative treatment approach.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • Histologically confirmed adenocarcinoma of the prostate
• • ECOG performance status 0-1
• • Life expectancy ≥ 12 weeks
• • WBC ≥ 3,500/µL
• • Platelet count ≥ 100,000/µL
• • Hemoglobin ≥ 10.0 g/dL
• • Creatinine ≤ 2.0 mg/dL
• • Alkaline phosphatase ≤ 2.5 times upper limit of normal (ULN)
• • AST ≤ 2.5 times ULN
• • Fertile patients must use effective contraception
• • Willing to provide blood samples for research purposes
• • Able to complete questionnaire(s) alone or with assistance
• • Able to undergo leukapheresis
• • No known immunodeficiency
• • No other malignancy within the past 5 years except for basal cell or squamous cell carcinoma of the skin treated with local resection only
• • No concurrent serious illness
• • No known history of positive PPD skin test
• • Human immunodeficiency virus (HIV) and Hepatitis C virus (HCV) test negative.
• Exclusion Criteria:
• • The patient was still using dexamethasone at a dose greater than 4 mg/day during mononuclear cell collection
• • Patients have a history of autoimmune diseases or other diseases requiring long-term use of hormones or immunosuppressive drugs
• • Patients with a history of allergies or allergies to immune cells and adjuvants of cellular products
• • Active infection with fever
• • Patients with neutropenia (\> 10 days) that are difficult to correct after treatment
• • Infection with bacteria, fungi or viruses, uncontrolled
• • Patients with HIV and those living with active HBV and HCV
• • Severe organ failure (heart, liver, kidney, lung)
• • Patients who had previously been treated with cell therapy products and examined by team experts deemed not suitable for treatment
• • Anything that researchers believe may increase the risk of subjects or interfere with test results