Exploring a new treatment to prevent cancer recurrence after surgery

Exploratory Study on Baize DC Injection in Preventing Recurrence and Metastasis After Radical Tumor Surgery

This study is testing a new treatment using immune cells to see if it can help prevent cancer from coming back after surgery in patients who are healthy and have no remaining signs of cancer.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Shanghai Cell Therapy Group Co.,Ltd (industry)
• Locations: 1 site (Shanghai, Shanghai)
• Trial ID: NCT06015269 on ClinicalTrials.gov

What this trial studies

This exploratory study investigates the safety, immune response, and preliminary effectiveness of a fixed dose therapy using dendritic cells in patients who have undergone radical surgery for malignant solid tumors. Participants will receive a single arm treatment of 1x10^7 cells after their surgery, with the aim of preventing recurrence and metastasis. The study will assess the immune response generated by the treatment and monitor for any adverse effects. It is designed for patients who are in good health post-surgery and have no signs of remaining cancer.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-80 with malignant solid tumors who have recently undergone radical resection surgery and show no signs of remaining disease.

Not a fit: Patients with advanced metastatic disease or those who do not meet the health criteria for participation may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce the risk of cancer recurrence and metastasis in patients after surgery.

How similar studies have performed: While this approach is exploratory, similar studies using dendritic cell therapies have shown promise in enhancing immune responses against tumors.

Eligibility criteria

Inclusion Criteria:

1. Age 18-80 years old, weight ≥ 40kg; No gender limit;
2. Subjects with malignant solid tumors diagnosed by histology or cytology and undergoing radical resection surgery;
3. 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);
4. Subjects in the safety verification stage need to provide immunohistochemical test results with positive expression of Survivin or P53;
5. ECOG score 0-1 points;
6. There are sufficient venous channels and no contraindications for peripheral blood mononuclear cell collection surgery;
7. Organs and bone marrow function well:

   1. Cardiac function: Left ventricular ejection fraction (LVEF) ≥ 50% evaluated by echocardiography within one month of enrollment; The electrocardiogram is basically normal;
   2. Platelets ≥ 90 × 10 \^ 9/L;
   3. Hemoglobin ≥ 90g/L (no blood transfusion or erythropoietin dependence within 7 days);
   4. Total bilirubin ≤ 2 times the upper limit of normal value;
   5. Serum creatinine ≤ 1.5 times the upper limit of normal value;
   6. Transaminases (AST, ALT) ≤ 2.5 times the upper limit of normal value (if liver cancer is 5 times the upper limit of normal value);
   7. International standardized ratio (INR) or prothrombin time (PT) ≤ 1.5 times the upper limit of normal value;
   8. Pulmonary function: ≤ CTCAE level 1 dyspnea and SaO2 ≥ 91% in indoor air environment;
8. Able to understand trial requirements and matters, willing to participate in clinical research according to trial requirements;

Exclusion Criteria:

1. 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;
2. Any uncontrollable active infection, coagulation disorder, or any other major disease;
3. Pregnant or lactating women
4. 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;
5. 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;
6. Major cardiovascular diseases with clinical significance include:

   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
7. Other situations where researchers believe it is not suitable to participate in clinical trials.

Where this trial is running

Shanghai, Shanghai

• Shanghai Mengchao Cancer Hospital — Shanghai, Shanghai, China (RECRUITING)

Study contacts

• Principal investigator: Lou jinxing — Shanghai Mengchao Cancer Hospital
• Study coordinator: Lou jinxing

Conditions: Solid Tumor, Solid tumor