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

Solid Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06015269
• Other study ID #: BZT003-A-01
• Status: Recruiting
• Phase: Phase 1
• Start date: August 2023
• Est. completion date: July 2025

Study information

• Verified date: August 2023
• Source: Shanghai Cell Therapy Group Co.,Ltd
• Contact: Lou jinxing
• Phone: 18911335396
• Email: loujx[@]shcell.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is an exploratory study on the safety, immune response, and preliminary effectiveness of single arm, fixed dose therapy

Description:

This study is a clinical study exploring the safety, immune response, and preliminary efficacy of a single arm, 1x107cells dose.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: July 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Recurrence
• Solid Tumor

Intervention

Drug:
• DC cells
At a single arm, 1x107cells dose

Locations

Country	Name	City	State
China	Shanghai Mengchao Cancer Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Cell Therapy Group Co.,Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose-limiting toxicity	Safety	within 1 months of single injection