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

NCT ID: NCT06015269

Last Updated: 2023-08-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-31
• Study Completion Date: 2025-07-31

Brief 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.

Conditions

Solid Tumor

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

DC cells

Super DC Vaccine (DC)

Group Type: EXPERIMENTAL

DC cells

Intervention Type: DRUG

At a single arm, 1x107cells dose

Interventions

DC cells

At a single arm, 1x107cells dose

Intervention Type: DRUG

Other Intervention Names

Super DC Vaccine (DC)

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Cell Therapy Group Co.,Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lou jinxing

Role: PRINCIPAL_INVESTIGATOR

Shanghai Mengchao Cancer Hospital

Locations

Shanghai Mengchao Cancer Hospital

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Lou jinxing

Role: CONTACT

loujx@shcell.com

18911335396

Zhang yan

Role: CONTACT

yan.zhang@shcell.com

18616657339

Facility Contacts

Lou jinxing

Role: primary

Zhang yan

Role: backup

Other Identifiers

BZT003-A-01

Identifier Type: -

Identifier Source: org_study_id