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

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

Study Overview

• Status: Recruiting
• Conditions: Solid Tumor
• Intervention / Treatment: Drug: DC cells

Detailed Description

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

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Lou jinxing; Phone Number: 18911335396; Email: loujx@shcell.com
• Study Contact Backup: Name: Zhang yan; Phone Number: 18616657339; Email: yan.zhang@shcell.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China
      • Recruiting
      • Shanghai Mengchao Cancer Hospital
      • Contact: Lou jinxing
      • Contact: Zhang yan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DC cells; Super DC Vaccine (DC)	Drug: DC cells; At a single arm, 1x107cells dose; Other Names: Super DC Vaccine (DC)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dose-limiting toxicity	Safety	within 1 months of single injection

Collaborators and Investigators

• Sponsor: Shanghai Cell Therapy Group Co.,Ltd
• Investigators: Principal Investigator: Lou jinxing, Shanghai Mengchao Cancer Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2023
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: August 23, 2023
• First Submitted That Met QC Criteria: August 23, 2023
• First Posted (Actual): August 29, 2023

Study Record Updates

• Last Update Posted (Actual): August 29, 2023
• Last Update Submitted That Met QC Criteria: August 23, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Solid tumor
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Recurrence; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: BZT003-A-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No