Prostate Cancer Vaccines

Phase 2TerminatedNCT07068555

Shenzhen Geno-Immune Medical Institute30 enrolled

Overview

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.

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

Allocation

Purpose

TREATMENT

Masking

NONE

Eligibility

Sex: MALEMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: up to one month

Secondary Outcomes

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.

Time frame: up to one month

Ability of prostate cancer DC vaccines to induce anti-cancer reaction

Measurement of specific T cell concentration in blood sample

Time frame: 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.

Time frame: 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.