Clinical trial · Interventional
Prostate Cancer Vaccines
Development of Prostate Cancer Dendritic Cell Vaccines
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer Indications | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Immunomodulatory DC vaccines to target prostate cancer | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Experimental: Immunomodulatory DC vaccines to target prostate cancer
- description
- Prostate tumor antigen-modified autologous DCs
- interventionNames
- Biological: Immunomodulatory DC vaccines to target prostate cancer
Primary outcomes (1)
- measure
- Events of adverse effects after the DC vaccine injection
- timeFrame
- up to one month
- description
- To assess the safety of autologous prostate cancer DC vaccine in vivo. The percentage of patients who have adverse effects will be evaluated by using the NCI CTCAE V4.0 criteria.
Secondary outcomes (4)
- measure
- Rate of successful prostate cancer DC vaccine generation
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available