Clinical Trials /

EGFR-IL12-CART Cells for Patients With Metastatic Colorectal Cancer

NCT03542799

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.

Related Conditions:
  • Colorectal Carcinoma
Recruiting Status:

Not yet recruiting

Phase:

Phase 1

Trial Eligibility

Document

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

DrugSynonymsArms
EGFR IL12 CART3

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

NameTypeDescriptionInterventions
3Experimentalanti-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