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

• Sponsor: Shanghai Cell Therapy Group Co.,Ltd (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT06015269
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 23
• Patients Per Site Per Month: 8.7

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Solid Tumor	Drug: DC cells	Phase 1

Detailed Description

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

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 200 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Exploratory Study on Baize DC Injection in Preventing Recurrence and Metastasis After Radical Tumor Surgery
• Anticipated Study Start Date: Aug 1, 2023
• Anticipated Primary Completion Date: Jul 1, 2025
• Anticipated Study Completion Date: Jul 1, 2025

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

1. Dose-limiting toxicity [within 1 months of single injection]

   Safety

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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:

8. Cardiac function: Left ventricular ejection fraction (LVEF) ≥ 50% evaluated by echocardiography within one month of enrollment; The electrocardiogram is basically normal;

9. Platelets ≥ 90 × 10 ^ 9/L;

10. Hemoglobin ≥ 90g/L (no blood transfusion or erythropoietin dependence within 7 days);

11. Total bilirubin ≤ 2 times the upper limit of normal value;

12. Serum creatinine ≤ 1.5 times the upper limit of normal value;

13. Transaminases (AST, ALT) ≤ 2.5 times the upper limit of normal value (if liver cancer is 5 times the upper limit of normal value);

14. International standardized ratio (INR) or prothrombin time (PT) ≤ 1.5 times the upper limit of normal value;

15. Pulmonary function: ≤ CTCAE level 1 dyspnea and SaO2 ≥ 91% in indoor air environment;

16. 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

1. Other situations where researchers believe it is not suitable to participate in clinical trials.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shanghai Mengchao Cancer Hospital	Shanghai	Shanghai	China

Sponsors and Collaborators

• Shanghai Cell Therapy Group Co.,Ltd

Investigators

• Principal Investigator: Lou jinxing, Shanghai Mengchao Cancer Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Shanghai Cell Therapy Group Co.,Ltd
• ClinicalTrials.gov Identifier: NCT06015269
• Other Study ID Numbers: BZT003-A-01
• First Posted: Aug 29, 2023
• Last Update Posted: Aug 29, 2023
• Last Verified: Aug 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Shanghai Cell Therapy Group Co.,Ltd: Solid tumor
• Additional relevant MeSH terms: Recurrence; Vaccines

Study Results

No Results Posted as of Aug 29, 2023