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

NCT06015269 | Unknown Phase 1 DMC

• 1 other identifier: BZT003-A-01
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Solid Tumor

Keywords

Solid tumor

Outcome Measures

Primary Outcomes (1)

• Dose-limiting toxicity

  Safety

  within 1 months of single injection

Study Arms (1)

DC cells

EXPERIMENTAL

Super DC Vaccine (DC)

Drug: DC cells

Interventions

DC cells DRUG

At a single arm, 1x107cells dose

Also known as: Super DC Vaccine (DC)

DC cells

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-80 years old, weight ≥ 40kg; No gender limit;
• Subjects with malignant solid tumors diagnosed by histology or cytology and undergoing radical resection surgery;
• 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;
• 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:
• Cardiac function: Left ventricular ejection fraction (LVEF) ≥ 50% evaluated by echocardiography within one month of enrollment; The electrocardiogram is basically normal;
• Platelets ≥ 90 × 10 \^ 9/L;
• Hemoglobin ≥ 90g/L (no blood transfusion or erythropoietin dependence within 7 days);
• Total bilirubin ≤ 2 times the upper limit of normal value;
• Serum creatinine ≤ 1.5 times the upper limit of normal value;
• Transaminases (AST, ALT) ≤ 2.5 times the upper limit of normal value (if liver cancer is 5 times the upper limit of normal value);
• International standardized ratio (INR) or prothrombin time (PT) ≤ 1.5 times the upper limit of normal value;
• Pulmonary function: ≤ CTCAE level 1 dyspnea and SaO2 ≥ 91% in indoor air environment;

You may not qualify if:

• 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;
• 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:
• 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
• Other situations where researchers believe it is not suitable to participate in clinical trials.

Sponsors & Collaborators

• Shanghai Cell Therapy Group Co.,Ltd: lead

Study Sites (1)

Shanghai Mengchao Cancer Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

Study Officials

• Lou jinxing

  Shanghai Mengchao Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lou jinxing

CONTACT

18911335396; loujx@shcell.com

Zhang yan

CONTACT

18616657339; yan.zhang@shcell.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2023
• First Posted: August 29, 2023
• Study Start: August 1, 2023
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: August 29, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR

Locations

CN (1)