Exploratory Study of Super DC Cell Injection in Preventing Recurrence After Radical Surgery for Tumors

Overview

The study is a controlled, open-label exploratory clinical trial.

Interventions

• Biological Super DC Vaccine
  Super DC Cell Injection

Primary outcome measures

• Dose-limiting toxicity [Time frame: Within 28 days after the first injection]

Eligibility criteria

Inclusion criteria

• 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;
• 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

Exclusion criteria

• 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:

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Non-randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• Shanghai Mengchao Tumor Hospital — Shanghai

Identifiers

NCT: NCT07146672 · BZT003-A-03

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗