Prostate Cancer Vaccines

Development of Prostate Cancer Dendritic Cell Vaccines

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.

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer Indications
• Intervention / Treatment: Biological: Immunomodulatory DC vaccines to target prostate cancer

Detailed Description

Prostate cancer is a malignancy originating from the epithelial cells of the prostate gland, ranking as the second most common cancer among men worldwide. Its etiology involves factors such as genetics, age, lifestyle (e.g., high-fat diet, obesity), and hormone levels. High-risk populations are typically men aged 45 and above.

Prostate cancer vaccines based on multiple target antigens derived from tumor lysates or synthetic peptides can serve as antigenic targets for immune cells. The vaccines involve immunomodulation with autologous DCs to stimulate and activate T cells in the body to target cancer cells. The principle of the DC vaccines is simple: to harness and enhance the body's anti-cancer immunity. The process involves simulating antigen-presenting cells with target tumor antigens in culture and then injecting patients with the modified antigen-presenting DCs. Early studies of DC-based vaccines targeting prostate cancer have shown high safety and low toxicity. Here, the study aims to evaluate the safety and efficacy of prostate cancer DC vaccines that use multiple target antigens based on prostate cancer cells to stimulate and induce a specific and strong anti-cancer immune response.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Lung-Ji Chang, PhD; Phone Number: +86 0755-86573763; Email: c@szgimi.org

Study Locations

• China
  • Guangdong
    • Shenzhen, Guangdong, China, 518000
      • Recruiting
      • Shenzhen Geno-immune Medical Institute
      • Contact: Lung-Ji Chang, PhD; Phone Number: +86 0755-86573763; Email: c@szgimi.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental: Immunomodulatory DC vaccines to target prostate cancer; Prostate tumor antigen-modified autologous DCs	Biological: Immunomodulatory DC vaccines to target prostate cancer; 1 to 2 injections, with an interval of one month, of 1~2x10^7 DC vaccine administered subcutaneously

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Events of adverse effects after the DC vaccine injection	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.	up to one month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of successful prostate cancer DC vaccine generation	The percentage of successful prostate cancer DC vaccine generation, which are derived from the monocytic cells of the subjects and pass the safety test after standard culture procedures, viable for at least one preparation, will be evaluated.	up to one month
Ability of prostate cancer DC vaccines to induce anti-cancer reaction	Measurement of specific T cell concentration in blood sample	after 1 month from prostate cancer DC injection to 12 months after injection
Ability of prostate cancer DC vaccines to induce an anti-cancer reaction	Objective response complete response (CR) is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria. CR indicates disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have shown reduction in short axis to <10 mm.	after 1 month from prostate cancer DC injection to 24 months after injection
Ability of prostate cancer DC vaccines to induce an anti-cancer reaction	Objective response partial response (PR)) is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria. Partial response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.	after 1 month from prostate cancer DC injection to 24 months after injection

Collaborators and Investigators

• Sponsor: Shenzhen Geno-Immune Medical Institute

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2025
• Primary Completion (Estimated): June 15, 2028
• Study Completion (Estimated): December 15, 2028

Study Registration Dates

• First Submitted: July 6, 2025
• First Submitted That Met QC Criteria: July 6, 2025
• First Posted (Actual): July 16, 2025

Study Record Updates

• Last Update Posted (Actual): July 20, 2025
• Last Update Submitted That Met QC Criteria: July 16, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: DC vaccine therapy
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: GIMI-IRB-25002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No