Prostate Cancer Vaccines

Shenzhen Geno-Immune Medical Institute

Status and phase

Enrolling

Phase 2

Phase 1

Conditions

Prostate Cancer Indications

Treatments

Biological: Immunomodulatory DC vaccines to target prostate cancer

Study type

Interventional

Funder types

Other

Identifiers

NCT07068555

GIMI-IRB-25002

Details and patient eligibility

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.

Full 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.

Enrollment

30 estimated patients

Sex

Male

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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