Super DC cell injections to prevent tumor recurrence after surgery.

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

This trial will test whether injections of a Super DC vaccine can help prevent solid tumors from coming back in adults who have had their tumors completely removed.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 12 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Shanghai Cell Therapy Group Co.,Ltd (Industry-sponsored)
• Locations: 1 site (Shanghai)
• Trial ID: NCT07146672 on ClinicalTrials.gov

What this trial studies

This is an open-label, controlled Phase 1/2 exploratory trial testing perioperative injections of a Super dendritic cell (Super DC) vaccine in patients who have undergone radical resection of malignant solid tumors. Eligible adults (18–80 years) with no evidence of disease on imaging and ECOG 0–1 will have peripheral blood mononuclear cells collected and receive one or more Super DC injections, with safety and recurrence monitored over time. A safety verification stage requires tumor immunohistochemistry positive for Survivin, P53, or MUC1, and patients will be followed with serial imaging and clinical assessments to compare recurrence rates to a control arm receiving standard follow-up. The trial is sponsored by Shanghai Cell Therapy Group and conducted at Shanghai Mengchao Tumor Hospital.

Who should consider this trial

Good fit: Adults 18–80 with resected malignant solid tumors, no residual or metastatic disease on recent imaging, ECOG 0–1, adequate blood and organ function, and (for the safety stage) tumor IHC positive for Survivin, P53, or MUC1 are ideal candidates.

Not a fit: Patients with residual tumor, distant or brain metastases, ECOG >1, inadequate blood counts or organ function, or who cannot undergo PBMC collection are unlikely to benefit from this trial.

Why it matters

Potential benefit: If successful, the vaccine could lower the risk of cancer coming back after surgery and extend disease-free survival.

How similar studies have performed: Dendritic cell vaccines have shown mixed results historically—sipuleucel-T showed a survival benefit in prostate cancer but many other DC vaccine trials have had limited or variable success—so this approach is partly tested but not broadly proven.

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:

Where this trial is running

Shanghai

• Shanghai Mengchao Tumor Hospital — Shanghai, China (Recruiting)

Conditions Solid Tumor Cancer; Vaccines; Immunologic Factors