Prostate Cancer Vaccines
Recruiting · NCT07068555 · Interventional (participants receive a specific treatment) · Lead sponsor: Shenzhen Geno-Immune Medical Institute
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
Tumor antigens are protein fragments produced by cancer cells carrying genetic mutations, and many tumor antigens are similar to normal protein antigens, making them unrecognizable by the immune system. Many tumor vaccines are prepared based on a single tumor antigen. This study is based on multiple target antigens using tumor lysates or synthetic peptides. The immune modulation by dendritic-cell (DC)-based cancer vaccines consists of genetically modified DCs to activate T cells to target cancer cells. The study is based on an advanced cancer vaccine technology, which aims to evaluate the safety and potential benefit of the novel immunomodulatory prostate cancer DC vaccines.
Who can take part
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
Where it is running
1 location listed.
- Shenzhen Geno-immune Medical Institute - Shenzhen, Guangdong, China