Dendritic-cell vaccine using multiple prostate cancer antigens
Development of Prostate Cancer Dendritic Cell Vaccines
This trial will test a personalized dendritic-cell vaccine made from multiple prostate cancer antigens to see if it is safe and helps men with prostate cancer.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | Male |
| Sponsor | Shenzhen Geno-Immune Medical Institute Academic / other |
| Locations | 1 site (Shenzhen, Guangdong) |
| Trial ID | NCT07068555 on ClinicalTrials.gov |
What this trial studies
This Phase 1/2 interventional trial uses autologous dendritic cells loaded with multiple tumor antigens derived from tumor lysates or synthetic peptides to stimulate T-cell responses against prostate adenocarcinoma. Participants undergo leukapheresis to collect immune cells which are modified in the laboratory and then reinfused as the vaccine in scheduled doses. The study will monitor safety, immune responses, and preliminary clinical signals such as PSA changes and radiographic findings. The protocol builds on earlier DC vaccine work that showed low toxicity while aiming to broaden anti-tumor immunity by targeting multiple antigens.
Who should consider this trial
Good fit: Ideal candidates are men with histologically confirmed prostate adenocarcinoma, ECOG performance status 0–1, adequate blood counts and organ function, able to undergo leukapheresis, and without known immunodeficiency.
Not a fit: Patients with active infections, known immunodeficiency, recent other malignancies, those taking high-dose steroids, or who cannot undergo leukapheresis are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the vaccine could safely boost the patient's immune system to slow disease progression or extend survival with fewer systemic side effects than conventional chemotherapy.
How similar studies have performed: Previous dendritic-cell vaccines for prostate cancer have shown good safety and at least one autologous cellular immunotherapy (sipuleucel-T) demonstrated a survival benefit, though many approaches remain experimental.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Shenzhen, Guangdong
- Shenzhen Geno-immune Medical Institute — Shenzhen, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Lung-Ji Chang, PhD
- Email: c@szgimi.org
- Phone: +86 0755-86573763
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.