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

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

Recruiting
18-80 years
All
Phase 1/2

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Overview

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

Eligibility

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:

Study details
    Solid Tumor Cancer

NCT07146672

Shanghai Cell Therapy Group Co.,Ltd

15 October 2025

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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