Back to resultsEGFR-IL12-CART Cells for Patients With Metastatic Colorectal Cancer (EGFRCART)
Primary Purpose
Metastatic Colorectal Cancer
Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
EGFR IL12 CART
Sponsored by
About this trial
This is an interventional treatment trial for Metastatic Colorectal Cancer
Eligibility Criteria
Inclusion Criteria:
- Patients must be 18 years to 70 years;
- Clinical diagnosis of EGFR positive for patients with metastatic colorectal cancer;
- Patients must have a KPS of >80, expected survival > 3 months;
- Patients must have at least one measurable lesions;
- Recently did not use glucocorticoid;
- Patients must have evidence of adequate hepatic and renal function as evidenced by the following laboratory parameters: WBC ≥ 3.0×109/L, Hb ≥90 g/L, PLT ≥100×109/L）; AST ≤2.5ULN，ALT ≤ 2.5ULN; Cr≤ 3ULN; TBIL≤ 3ULN，
- Patients must have a good heart function (LVEF>50%) ;
- Patients must be willing to practice birth control during and for three months following treatment.NOTE:female participants of reproductive potential must have a negative serum pregnancy test, and willing to practice birth control during and for three months following treatment；
- Patients must be willing to sign an informed consent.
Exclusion Criteria:
- Patients with other cancer history;
- Patients allergic to cetuximab;
- Patients with severe bronchitis, bronchial asthma, or severs pneumonia;
- Patients with uncontrolled active infections (bacteria, viruses or fungi infection) ;
- Patients with acute and chronic GVHD (graft versus host disease)
- Patients with severe autoimmune diseases;
- Previously treatment with T cell inhibitors (cyclophosphamide, FK506);
- Patients with active hepatitis B or hepatitis C infection, HIV infection, syphilis serology reaction positive;
- Patients who are participating or participated any other clinical research in the past 1 months;
- Pregnant and/or lactating women will be excluded; -
Sites / Locations
- Geng Tian 13724395569 Tiangeng666@Aliyun.Com
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
3
Arm Description
anti-tumor response of EGFR IL12 CART
Outcomes
Primary Outcome Measures
Safety: Occurrence of study related adverse events
Occurrence of study related adverse events as assessed by CTCAE v4.0
Secondary Outcome Measures
Effectiveness: Changes of tumor markers
Changes of tumor markers CA-199, AFP and CEA
Effectiveness: duration of in vivo survival of EGFR CART
Determine duration of in vivo survival of EGFR CART
Full Information
NCT ID
NCT03542799
First Posted
May 18, 2018
Last Updated
May 30, 2018
Sponsor
Shenzhen Second People's Hospital
Collaborators
The Pregene (ShenZhen) Biotechnology Company, Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03542799
Brief Title
EGFR-IL12-CART Cells for Patients With Metastatic Colorectal Cancer
Acronym
EGFRCART
Official Title
Phase I/II Study of EGFR-IL12-CART Cells for Patients With Metastatic Colorectal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Unknown status
Study Start Date
May 22, 2018 (Anticipated)
Primary Completion Date
May 23, 2020 (Anticipated)
Study Completion Date
May 23, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shenzhen Second People's Hospital
Collaborators
The Pregene (ShenZhen) Biotechnology Company, Ltd.
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 is a clinical study to observe the maximum tolerated dose (MTD) and the safety and feasibility of chimeric antigen receptor EGFR (EGFR -IL12 -CART) cells in metastatic patients with colorectal cancer.
Detailed Description
This is a study for the patients with colorectal cancer. Maximum tolerated dose climbing test is expected into the group of 9 cases of patients. And Phase II expected into the group of 11 subjects, selected the above safe dose, carrying out a research into the clinical effectiveness. Subjects will be collected their T cells and modify them, the modification is a genetic change, that EGFR:4-1BB:CD28:CD3 modified T cells, in order to tells the T cells to recognize their target tumor cells and potentially kill them, but not other normal cells in the subject's body. The CART cells will then be expanded in vitro and then administered to subjects. Fourth generation CART, also known as TRUCKs (T cells redirected for universal cytokine before), mainly in order to improve the effect of solid tumor treatment and design, through NFAT transcription factors inducing expression of IL - 12, overcome the solid tumor within the tumor microenvironment of CART limit the function of cellsThe purpose of this study is observe the MTD and to assess the safety and feasibility of CART cells in the patients with metastatic colorectal cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Colorectal Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
3
Arm Type
Experimental
Arm Description
anti-tumor response of EGFR IL12 CART
Intervention Type
Biological
Intervention Name(s)
EGFR IL12 CART
Intervention Description
EGFR IL12 CART cells will be administered using a split dose on day0 (10%),1(30%), and 2(60%)
Primary Outcome Measure Information:
Title
Safety: Occurrence of study related adverse events
Description
Occurrence of study related adverse events as assessed by CTCAE v4.0
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Effectiveness: Changes of tumor markers
Description
Changes of tumor markers CA-199, AFP and CEA
Time Frame
24 weeks
Title
Effectiveness: duration of in vivo survival of EGFR CART
Description
Determine duration of in vivo survival of EGFR CART
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients must be 18 years to 70 years;
Clinical diagnosis of EGFR positive for patients with metastatic colorectal cancer;
Patients must have a KPS of >80, expected survival > 3 months;
Patients must have at least one measurable lesions;
Recently did not use glucocorticoid;
Patients must have evidence of adequate hepatic and renal function as evidenced by the following laboratory parameters: WBC ≥ 3.0×109/L, Hb ≥90 g/L, PLT ≥100×109/L）; AST ≤2.5ULN，ALT ≤ 2.5ULN; Cr≤ 3ULN; TBIL≤ 3ULN，
Patients must have a good heart function (LVEF>50%) ;
Patients must be willing to practice birth control during and for three months following treatment.NOTE:female participants of reproductive potential must have a negative serum pregnancy test, and willing to practice birth control during and for three months following treatment；
Patients must be willing to sign an informed consent.
Exclusion Criteria:
Patients with other cancer history;
Patients allergic to cetuximab;
Patients with severe bronchitis, bronchial asthma, or severs pneumonia;
Patients with uncontrolled active infections (bacteria, viruses or fungi infection) ;
Patients with acute and chronic GVHD (graft versus host disease)
Patients with severe autoimmune diseases;
Previously treatment with T cell inhibitors (cyclophosphamide, FK506);
Patients with active hepatitis B or hepatitis C infection, HIV infection, syphilis serology reaction positive;
Patients who are participating or participated any other clinical research in the past 1 months;
Pregnant and/or lactating women will be excluded; -
Facility Information:
Facility Name
Geng Tian 13724395569 Tiangeng666@Aliyun.Com
City
Shenzhen
State/Province
GuangGong
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
geng tian, DOCTOR
Phone
13724395569
Email
tiangeng666@aliyun.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
EGFR-IL12-CART Cells for Patients With Metastatic Colorectal Cancer
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