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Can a custom vaccine train the body to fight prostate cancer?

NCT ID NCT07068555

Vaccine Sponsor: Shenzhen Geno-Immune Medical Institute Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 24, 2026 · Last updated Aug 25, 2026 · Updated 1 time

Summary

This early-stage trial is testing a personalized vaccine made from a patient's own immune cells (dendritic cells) to treat prostate cancer. The vaccine is designed to teach the immune system to recognize and attack cancer cells by targeting multiple tumor antigens. The study involves about 30 participants with prostate cancer and aims to evaluate the vaccine's safety and potential benefit.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
A personalized dendritic cell vaccine made from the patient's own immune cells, designed to target multiple prostate cancer antigens.
What this could lead to
If successful, this approach could lead to a new immunotherapy option for prostate cancer that trains the body's own immune system to attack cancer cells.
What could go wrong
This is an early-phase trial with a small number of participants, so the vaccine may not prove effective or safe in larger groups. Possible side effects include immune-related reactions.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

30 people

The number who actually took part.

Started

Jun 2025

Finished

Jul 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

prostate adenocarcinoma prostate cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Prostate cancer indications

Contacts and locations

Locations

  • Shenzhen Geno-immune Medical Institute

    Shenzhen, Guangdong, 518000, China

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