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

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorShanghai Cell Therapy Group Co.,Ltd

About this trial

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

Eligibility criteria

Qualifiers

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;

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • Super DC Vaccine

Treatment groups

12 Participants
are divided into 2 treatment groups