Back to resultsPersonalized Immune Cell Therapy Targeting Neoantigen of Malignant Solid Tumors
Primary Purpose
Carcinoma, Melanoma, Bladder Cancer
Status
Not yet recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Tumor antigen-sensitized DC vaccine and their sensitized T cells subcutaneous administration
Sponsored by
About this trial
This is an interventional treatment trial for Carcinoma focused on measuring Melanoma, Bladder Cancer, Colorectal Cancer, tumor neo-antigen DC vaccine, safety, clinical efficacy
Eligibility Criteria
Inclusion Criteria:
- Age:18-75 years
- Pathologically diagnosed advanced (stage IV) malignant melanoma, bladder cancer or colorectal cancer with measurable lesions;
- Failed in the previous standard therapy;
- ECOG PS (Eastern Cooperative Oncology Group performance status) score 0-2 points;
- The estimated survival period is ≥3 months;
- Rehabilitate from previous therapy;
- Adequate organ functions;
- Patient's written informed consent;
Exclusion Criteria:
- Tumor emergencies;
- Abnormal coagulation function;
- Contagious diseases, such as HIV, HBV, HCV infection;
- Mental disorders;
- Concomitant tumors;
- Immunological co-morbidities
Sites / Locations
- West China Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Tumor antigen-sensitized vaccine and their sensitized T cells
Arm Description
Tumor antigen-sensitized vaccine is administrated, 1- week interval, totally 2 times. Then, Neo-antigen DC vaccine and their sensitized T cells are administrated, 2-week interval, totally 5 times.
Outcomes
Primary Outcome Measures
Number of participants with treatment-related adverse events as events as assessed by CTCAE v4.0
Number of participants with treatment-related adverse events as events as assessed by CTCAE v4.0
Secondary Outcome Measures
Number of participants with Overall survival as assessed by RECIST1.1
Full Information
NCT ID
NCT05235607
First Posted
December 19, 2021
Last Updated
February 10, 2022
Sponsor
Sichuan University
1. Study Identification
Unique Protocol Identification Number
NCT05235607
Brief Title
Personalized Immune Cell Therapy Targeting Neoantigen of Malignant Solid Tumors
Official Title
Personalized Immune Cell Therapy Targeting Neoantigen of Malignant Solid Tumors
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 1, 2022 (Anticipated)
Primary Completion Date
June 1, 2023 (Anticipated)
Study Completion Date
December 2, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sichuan University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This single center, single arm and prospective study aimed to establish gene mutation database and select the neoantigens in patients with advanced malignant melanoma, bladder cancer and colorectal cancer. Then, we intended to explore the safety and efficacy of individual tumor antigen-sensitized DC vaccine and their sensitized T cells in these solid cancers.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Melanoma, Bladder Cancer, Colorectal Cancer
Keywords
Melanoma, Bladder Cancer, Colorectal Cancer, tumor neo-antigen DC vaccine, safety, clinical efficacy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Tumor antigen-sensitized vaccine and their sensitized T cells
Arm Type
Experimental
Arm Description
Tumor antigen-sensitized vaccine is administrated, 1- week interval, totally 2 times.
Then, Neo-antigen DC vaccine and their sensitized T cells are administrated, 2-week interval, totally 5 times.
Intervention Type
Biological
Intervention Name(s)
Tumor antigen-sensitized DC vaccine and their sensitized T cells subcutaneous administration
Intervention Description
subcutaneous administration
Primary Outcome Measure Information:
Title
Number of participants with treatment-related adverse events as events as assessed by CTCAE v4.0
Description
Number of participants with treatment-related adverse events as events as assessed by CTCAE v4.0
Time Frame
3 months after the last administration of cells
Secondary Outcome Measure Information:
Title
Number of participants with Overall survival as assessed by RECIST1.1
Time Frame
through study completion, an average of 1 year
10. Eligibility
Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age:18-75 years
Pathologically diagnosed advanced (stage IV) malignant melanoma, bladder cancer or colorectal cancer with measurable lesions;
Failed in the previous standard therapy;
ECOG PS (Eastern Cooperative Oncology Group performance status) score 0-2 points;
The estimated survival period is ≥3 months;
Rehabilitate from previous therapy;
Adequate organ functions;
Patient's written informed consent;
Exclusion Criteria:
Tumor emergencies;
Abnormal coagulation function;
Contagious diseases, such as HIV, HBV, HCV infection;
Mental disorders;
Concomitant tumors;
Immunological co-morbidities
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ji-Yan Liu, Prof
Phone
028-85422039
Email
liujiyan1972@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ji-Yan Liu
Organizational Affiliation
Sichuan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
West China Hospital
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610000
Country
China
12. IPD Sharing Statement
Learn more about this trial
Personalized Immune Cell Therapy Targeting Neoantigen of Malignant Solid Tumors
We'll reach out to this number within 24 hrs