Description:
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.
Title
- Brief Title: EGFR-IL12-CART Cells for Patients With Metastatic Colorectal Cancer
- Official Title: Phase I/II Study of EGFR-IL12-CART Cells for Patients With Metastatic Colorectal Cancer
Clinical Trial IDs
- ORG STUDY ID:
Protocol. PGCAR/EGFR012
- NCT ID:
NCT03542799
Conditions
- Metastatic Colorectal Cancer
Interventions
Drug | Synonyms | Arms |
---|
EGFR IL12 CART | | 3 |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
3 | Experimental | anti-tumor response of EGFR IL12 CART | |
Eligibility Criteria
Inclusion Criteria:
1. Patients must be 18 years to 70 years;
2. Clinical diagnosis of EGFR positive for patients with metastatic colorectal cancer;
3. Patients must have a KPS of >80, expected survival > 3 months;
4. Patients must have at least one measurable lesions;
5. Recently did not use glucocorticoid;
6. 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,
7. Patients must have a good heart function (LVEF>50%) ;
8. 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;
9. Patients must be willing to sign an informed consent.
Exclusion Criteria:
1. Patients with other cancer history;
2. Patients allergic to cetuximab;
3. Patients with severe bronchitis, bronchial asthma, or severs pneumonia;
4. Patients with uncontrolled active infections (bacteria, viruses or fungi infection) ;
5. Patients with acute and chronic GVHD (graft versus host disease)
6. Patients with severe autoimmune diseases;
7. Previously treatment with T cell inhibitors (cyclophosphamide, FK506);
8. Patients with active hepatitis B or hepatitis C infection, HIV infection, syphilis
serology reaction positive;
9. Patients who are participating or participated any other clinical research in the past
1 months;
10. Pregnant and/or lactating women will be excluded; -
Maximum Eligible Age: | 70 Years |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Safety: Occurrence of study related adverse events |
Time Frame: | 24 weeks |
Safety Issue: | |
Description: | Occurrence of study related adverse events as assessed by CTCAE v4.0 |
Secondary Outcome Measures
Measure: | Effectiveness: Changes of tumor markers |
Time Frame: | 24 weeks |
Safety Issue: | |
Description: | Changes of tumor markers CA-199, AFP and CEA |
Measure: | Effectiveness: duration of in vivo survival of EGFR CART |
Time Frame: | 1 year |
Safety Issue: | |
Description: | Determine duration of in vivo survival of EGFR CART |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Not yet recruiting |
Lead Sponsor: | Shenzhen Second People's Hospital |
Last Updated
May 31, 2018