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

Primary Purpose

Solid Tumor

Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
DC cells
Sponsored by
Shanghai Cell Therapy Group Co.,Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Solid Tumor focused on measuring Solid tumor

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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; Able to understand trial requirements and matters, willing to participate in clinical research according to trial requirements; Exclusion Criteria: 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.

Sites / Locations

  • Shanghai Mengchao Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

DC cells

Arm Description

Super DC Vaccine (DC)

Outcomes

Primary Outcome Measures

Dose-limiting toxicity
Safety

Secondary Outcome Measures

Full Information

First Posted
August 23, 2023
Last Updated
August 23, 2023
Sponsor
Shanghai Cell Therapy Group Co.,Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT06015269
Brief Title
Exploratory Study on Baize DC Injection in Preventing Recurrence and Metastasis After Radical Tumor Surgery
Official Title
Exploratory Study on Baize DC Injection in Preventing Recurrence and Metastasis After Radical Tumor Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 2023 (Anticipated)
Primary Completion Date
July 2025 (Anticipated)
Study Completion Date
July 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Cell Therapy Group Co.,Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Solid Tumor
Keywords
Solid tumor

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
DC cells
Arm Type
Experimental
Arm Description
Super DC Vaccine (DC)
Intervention Type
Drug
Intervention Name(s)
DC cells
Other Intervention Name(s)
Super DC Vaccine (DC)
Intervention Description
At a single arm, 1x107cells dose
Primary Outcome Measure Information:
Title
Dose-limiting toxicity
Description
Safety
Time Frame
within 1 months of single injection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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; Able to understand trial requirements and matters, willing to participate in clinical research according to trial requirements; Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lou jinxing
Phone
18911335396
Email
loujx@shcell.com
First Name & Middle Initial & Last Name or Official Title & Degree
Zhang yan
Phone
18616657339
Email
yan.zhang@shcell.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lou jinxing
Organizational Affiliation
Shanghai Mengchao Cancer Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Mengchao Cancer Hospital
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lou jinxing
First Name & Middle Initial & Last Name & Degree
Zhang yan

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

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

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