Prostate Cancer IndicationsPhase 1/2NCT07068555
Prostate Cancer Vaccines
A Phase 1/2 study testing Immunomodulatory DC vaccines to target prostate cancer in people with Prostate Cancer Indications, run by Shenzhen Geno-Immune Medical Institute at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Prostate Cancer Indications
- What is being tested?
- Immunomodulatory DC vaccines to target prostate cancer
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 15 Jun 2025to 31 Jul 2026
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Prostate Cancer Indications
- Being tested
- Immunomodulatory DC vaccines to target prostate cancer
- Keywords
- DC vaccine therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immunomodulatory DC vaccines to target prostate cancerBiological
1 to 2 injections, with an interval of one month, of 1~2x10^7 DC vaccine administered subcutaneously
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Immunomodulatory DC vaccines to target prostate cancer | Experimental | Prostate tumor antigen-modified autologous DCs Receives: Biological: Immunomodulatory DC vaccines to target prostate cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to one month
Secondary outcomes (4)
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.
Measured: up to one month
Ability of prostate cancer DC vaccines to induce anti-cancer reaction
Measurement of specific T cell concentration in blood sample
Measured: 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.
Measured: 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.
Measured: after 1 month from prostate cancer DC injection to 24 months after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2025
- Study start15 Jun 2025
- Primary completion15 Jul 2026
- Study completion31 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Cancer IndicationsStudies of the same condition, open and under way.
- More trials run by Shenzhen Geno-Immune Medical InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shenzhen Geno-Immune Medical Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07068555
- Sponsor's protocol ID
- GIMI-IRB-25002
- Status last verified
- Oct 2026
- First submitted
- 6 Jul 2025
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Prostate Cancer Dendritic Cell Vaccines
- ClinicalTrials.gov ID
- NCT07068555
- Acronym / sponsor ID
- GIMI-IRB-25002
- Conditions
- Prostate Cancer Indications
- Keywords
- DC vaccine therapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Shenzhen Geno-Immune Medical InstituteUniversity, hospital or other
- Study start
- 15 Jun 2025 (actual)
- Primary completion
- 15 Jul 2026 (actual)
- Study completion
- 31 Jul 2026 (actual)
- First posted
- 16 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: Immunomodulatory DC vaccines to target prostate cancer | Experimental | Biological: Immunomodulatory DC vaccines to target prostate cancerProstate tumor antigen-modified autologous DCs |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Histologically confirmed adenocarcinoma of the prostate
- ECOG performance status 0-1
- Life expectancy ≥ 12 weeks
- WBC ≥ 3,500/µL
- Platelet count ≥ 100,000/µL
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immunomodulatory DC vaccines to target prostate cancer1 to 2 injections, with an interval of one month, of 1~2x10^7 DC vaccine administered subcutaneously | Biological | Experimental: Immunomodulatory DC vaccines to target prostate cancer |
Primary outcome
Events of adverse effects after the DC vaccine injection
Time frame: up to one month
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.
4 secondary outcomes
Rate of successful prostate cancer DC vaccine generation
Time frame: up to one month
Ability of prostate cancer DC vaccines to induce anti-cancer reaction
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
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
Time frame: after 1 month from prostate cancer DC injection to 24 months after injection
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Immunomodulatory DC vaccines to target prostate cancer in people with Prostate Cancer Indications, run by Shenzhen Geno-Immune Medical Institute at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Events of adverse effects after the DC vaccine injection (time frame: up to one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.