Solid Tumor CancerPhase 1/2NCT07146672
Exploratory Study of Super DC Cell Injection in Preventing Recurrence After Radical Surgery for Tumors
A Phase 1/2 study testing Super DC Vaccine in people with Solid Tumor Cancer, run by Shanghai Cell Therapy Group Co.,Ltd at 1 site in China.
Trial summary
The study is a controlled, open-label exploratory clinical trial. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Solid Tumor Cancer
- What is being tested?
- Super DC Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 31 Jul 2025to 31 Dec 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-80 years old, weight ≥ 40kg; No gender limit；
- Subjects with malignant solid tumors diagnosed by histology or cytology and undergoing radical resection surger；
- At the beginning of the study (after surgery), there were no lesions, no local recurrence or distant metastasis on the imaging, and no brain metastasis (images within one month before enrollment can be used for screening)；
- Subjects in the safety verification stage need to provide immunohistochemical test results with positive expression of Survivin or P53 or MUC1;
- ECOG score 0-1 points;
- There are sufficient venous channels and no contraindications for peripheral blood mononuclear cell collection surgery;
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- Organs and bone marrow function well:
- a:Cardiac function: Left ventricular ejection fraction (LVEF) ≥ 50% evaluated by echocardiography within one month of enrollment; The electrocardiogram is basically normal;
- b:Platelets ≥ 90 × 10 ^ 9/L;
- c:Hemoglobin ≥ 90g/L (no blood transfusion or erythropoietin dependence within 7 days);
- d:Total bilirubin ≤ 2 times the upper limit of normal value;
- e:Serum creatinine ≤ 1.5 times the upper limit of normal value;
- f:Transaminases (AST, ALT) ≤ 2.5 times the upper limit of normal value (if liver cancer is 5 times the upper limit of normal value);
- g:International standardized ratio (INR) or prothrombin time (PT) ≤ 1.5 times the upper limit of normal value;
- Able to understand trial requirements and matters, willing to participate in clinical research according to trial requirements
Who cannot join
- Positive for HIV antibodies or syphilis antibodies; positive for hepatitis B surface antigen, and positive for hepatitis B core antibody or e antibody with viral DNA copy number above the detection limit or ≥1000 copies/ml; or hepatitis C virus RNA copy number above the detection limit.
- Any uncontrollable active infection, coagulation disorder, or any other major disease;
- Pregnant or lactating women;
- Suffering from active neuroautoimmune or inflammatory diseases, such as any of the following: inflammatory bowel disease, systemic lupus erythematosus, ankylosing spondylitis, scleroderma, multiple sclerosis, Sjogren's syndrome, etc., and receiving relevant treatment; Subjects who are still using immunosuppressants for organ transplantation; Or subjects who have been using immunosuppressive drugs such as glucocorticoids for a long time cannot stop at least 4 weeks before enrollment; Severe allergic constitution;
- Subjects with existing abnormalities in the central nervous system, such as seizures, cerebral vascular ischemia/bleeding, dementia, cerebellar diseases, or any autoimmune diseases associated with central nervous system involvement;
- Major cardiovascular diseases with clinical significance include:
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Mengchao Tumor Hospital
Shanghai
Lou Jinxing, 021-67091012, loujx@shcell.com
About this study
The study is a controlled, open-label exploratory clinical trial.
- Conditions
- Solid Tumor Cancer
- Being tested
- Super DC Vaccine
- Keywords
- Vaccines, Immunologic Factors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Super DC VaccineBiological
Super DC Cell Injection
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | A single dose of 1×10^7 cells, with a dosing interval of 1 week or 2 weeks during the induction period. Receives: Biological: Super DC Vaccine |
| Group 2 | Experimental | A single dose of 2×10^7 cells, with a dosing interval of 1 week or 2 weeks during the induction period. Receives: Biological: Super DC Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicity
Safety
Measured: Within 28 days after the first injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2025
- Study start31 Jul 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumor CancerStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Cell Therapy Group Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07146672
- Sponsor's protocol ID
- BZT003-A-03
- Status last verified
- Aug 2025
- First submitted
- 21 Aug 2025
- Last updated
- 28 Aug 2025
- 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 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study of Super DC Cell Injection in Preventing Recurrence After Radical Surgery for Tumors
- ClinicalTrials.gov ID
- NCT07146672
- Acronym / sponsor ID
- BZT003-A-03
- Conditions
- Solid Tumor Cancer
- Keywords
- Vaccines, Immunologic Factors
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Shanghai Cell Therapy Group Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- 31 Jul 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 28 Aug 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.
The study is a controlled, open-label exploratory clinical trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Biological: Super DC VaccineA single dose of 1×10^7 cells, with a dosing interval of 1 week or 2 weeks during the induction period. |
| Group 2 | Experimental | Biological: Super DC VaccineA single dose of 2×10^7 cells, with a dosing interval of 1 week or 2 weeks during the induction period. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Age 18-80 years old, weight ≥ 40kg; No gender limit；
- Subjects with malignant solid tumors diagnosed by histology or cytology and undergoing radical resection surger；
- At the beginning of the study (after surgery), there were no lesions, no local recurrence or distant metastasis on the imaging, and no brain metastasis (images within one month before enrollment can be used for screening)；
- Subjects in the safety verification stage need to provide immunohistochemical test results with positive expression of Survivin or P53 or MUC1;
- ECOG score 0-1 points;
Key exclusion criteria (6 listed)
- Positive for HIV antibodies or syphilis antibodies; positive for hepatitis B surface antigen, and positive for hepatitis B core antibody or e antibody with viral DNA copy number above the detection limit or ≥1000 copies/ml; or hepatitis C virus RNA copy number above the detection limit.
- Any uncontrollable active infection, coagulation disorder, or any other major disease;
- Pregnant or lactating women;
- Suffering from active neuroautoimmune or inflammatory diseases, such as any of the following: inflammatory bowel disease, systemic lupus erythematosus, ankylosing spondylitis, scleroderma, multiple sclerosis, Sjogren's syndrome, etc., and receiving relevant treatment; Subjects who are still using immunosuppressants for organ transplantation; Or subjects who have been using immunosuppressive drugs such as glucocorticoids for a long time cannot stop at least 4 weeks before enrollment; Severe allergic constitution;
- Subjects with existing abnormalities in the central nervous system, such as seizures, cerebral vascular ischemia/bleeding, dementia, cerebellar diseases, or any autoimmune diseases associated with central nervous system involvement;
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 |
|---|---|---|
| Super DC VaccineSuper DC Cell Injection | Biological | Group 1, Group 2 |
Primary outcome
Dose-limiting toxicity
Time frame: Within 28 days after the first injection
Safety
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2025.
- 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.
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 Super DC Vaccine in people with Solid Tumor Cancer, run by Shanghai Cell Therapy Group Co.,Ltd 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 15 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 28 Aug 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-limiting toxicity (time frame: Within 28 days after the first injection). 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 28 Aug 2025.