Solid TumorPhase 1NCT06015269
Exploratory Study on Baize DC Injection in Preventing Recurrence and Metastasis After Radical Tumor Surgery
A Phase 1 study testing DC cells in people with Solid Tumor, run by Shanghai Cell Therapy Group Co.,Ltd at 1 site in China.
Trial summary
This is an exploratory study on the safety, immune response, and preliminary effectiveness of single arm, fixed dose therapy Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Solid Tumor
- What is being tested?
- DC cells
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Aug 2023to Jul 2025
- Phase
- Phase 1
- 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
- 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 surgery;
- 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;
- 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:
- Cardiac function: Left ventricular ejection fraction (LVEF) ≥ 50% evaluated by echocardiography within one month of enrollment; The electrocardiogram is basically normal;
- Platelets ≥ 90 × 10 ^ 9/L;
- Hemoglobin ≥ 90g/L (no blood transfusion or erythropoietin dependence within 7 days);
- Total bilirubin ≤ 2 times the upper limit of normal value;
- Serum creatinine ≤ 1.5 times the upper limit of normal value;
- Transaminases (AST, ALT) ≤ 2.5 times the upper limit of normal value (if liver cancer is 5 times the upper limit of normal value);
- International standardized ratio (INR) or prothrombin time (PT) ≤ 1.5 times the upper limit of normal value;
- Pulmonary function: ≤ CTCAE level 1 dyspnea and SaO2 ≥ 91% in indoor air environment;
- Able to understand trial requirements and matters, willing to participate in clinical research according to trial requirements;
Who cannot join
- HIV and syphilis serological reactions were positive; Hepatitis B surface antigen is positive, hepatitis B core antibody is positive, and the copy number of hepatitis B virus DNA is higher than the lower limit of detection and or greater than or equal to 1000 copies/ml; Or hepatitis C virus infected individuals;
- 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:
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- Symptomatic congestive heart failure
- B Unstable angina pectoris
- Severe arrhythmia requiring medication treatment
- Uncontrolled hypertension
- Myocardial infarction or ventricular arrhythmia within 6 months prior to screening
- Other situations where researchers believe it is not suitable to participate in clinical trials.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Mengchao Cancer Hospital
Shanghai, Shanghai Municipality
Lou jinxing
Zhang yan
About this study
This is an exploratory study on the safety, immune response, and preliminary effectiveness of single arm, fixed dose therapy
Read the detailed description
This study is a clinical study exploring the safety, immune response, and preliminary efficacy of a single arm, 1x107cells dose.
- Conditions
- Solid Tumor
- Being tested
- DC cells
- Keywords
- Solid tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DC cellsDrug
Also called Super DC Vaccine (DC)
At a single arm, 1x107cells dose
| Study group | Role | What they receive |
|---|---|---|
| DC cells | Experimental | Super DC Vaccine (DC) Receives: Drug: DC cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicity
Safety
Measured: within 1 months of single injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2023
- Study startAug 2023 (estimated)
- Primary completionJul 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies 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
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Cell Therapy Group Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lou jinxing, Principal investigator, Shanghai Mengchao Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06015269
- Sponsor's protocol ID
- BZT003-A-01
- Status last verified
- Aug 2023
- First submitted
- 23 Aug 2023
- Last updated
- 29 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study on Baize DC Injection in Preventing Recurrence and Metastasis After Radical Tumor Surgery
- ClinicalTrials.gov ID
- NCT06015269
- Acronym / sponsor ID
- BZT003-A-01
- Conditions
- Solid Tumor
- Keywords
- Solid tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Shanghai Cell Therapy Group Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- Aug 2023 (estimated)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 29 Aug 2023 (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.
This is an exploratory study on the safety, immune response, and preliminary effectiveness of single arm, fixed dose therapy
Detailed description
This study is a clinical study exploring the safety, immune response, and preliminary efficacy of a single arm, 1x107cells dose.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DC cells | Experimental | Drug: DC cellsSuper DC Vaccine (DC) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 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 surgery;
- 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;
- ECOG score 0-1 points;
Key exclusion criteria (12 listed)
- HIV and syphilis serological reactions were positive; Hepatitis B surface antigen is positive, hepatitis B core antibody is positive, and the copy number of hepatitis B virus DNA is higher than the lower limit of detection and or greater than or equal to 1000 copies/ml; Or hepatitis C virus infected individuals;
- 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 |
|---|---|---|
| DC cellsAlso: Super DC Vaccine (DC)At a single arm, 1x107cells dose | Drug | DC cells |
Primary outcome
Dose-limiting toxicity
Time frame: within 1 months of single injection
Safety
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2023.
- Individual participant dataSharing planned: Yes
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Advanced Solid Tumor
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.
Lou jinxing principal investigator
Shanghai Mengchao Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DC cells in people with Solid Tumor, 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 16 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 29 Aug 2023. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lou jinxing (18911335396, loujx@shcell.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-limiting toxicity (time frame: within 1 months of single 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 29 Aug 2023; AzTrials last refreshed its copy on 29 Oct 2026.