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Trial Title:
Exploratory Study on Baize DC Injection in Preventing Recurrence and Metastasis After Radical Tumor Surgery
NCT ID:
NCT06015269
Condition:
Solid Tumor
Conditions: Official terms:
Recurrence
Vaccines
Conditions: Keywords:
Solid tumor
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Prevention
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
DC cells
Description:
At a single arm, 1x107cells dose
Arm group label:
DC cells
Other name:
Super DC Vaccine (DC)
Summary:
This is an exploratory study on the safety, immune response, and preliminary
effectiveness of single arm, fixed dose therapy
Detailed description:
This study is a clinical study exploring the safety, immune response, and preliminary
efficacy of a single arm, 1x107cells dose.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Shanghai Mengchao Cancer Hospital
Address:
City:
Shanghai
Country:
China
Status:
Recruiting
Contact:
Last name:
Lou jinxing
Contact backup:
Last name:
Zhang yan
Start date:
August 2023
Completion date:
July 2025
Lead sponsor:
Agency:
Shanghai Cell Therapy Group Co.,Ltd
Agency class:
Industry
Source:
Shanghai Cell Therapy Group Co.,Ltd
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06015269
