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EGFR-IL12-CART Cells for Patients With Metastatic Colorectal Cancer (EGFRCART)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03542799
Recruitment Status : Unknown
Verified May 2018 by tiangeng, Shenzhen Second People's Hospital.
Recruitment status was:  Not yet recruiting
First Posted : May 31, 2018
Last Update Posted : May 31, 2018
The Pregene (ShenZhen) Biotechnology Company, Ltd.
Information provided by (Responsible Party):
tiangeng, Shenzhen Second People's Hospital

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.

Condition or disease Intervention/treatment Phase
Metastatic Colorectal Cancer Biological: EGFR IL12 CART Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I/II Study of EGFR-IL12-CART Cells for Patients With Metastatic Colorectal Cancer
Estimated Study Start Date : May 22, 2018
Estimated Primary Completion Date : May 23, 2020
Estimated Study Completion Date : May 23, 2021

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 3
anti-tumor response of EGFR IL12 CART
Biological: EGFR IL12 CART
EGFR IL12 CART cells will be administered using a split dose on day0 (10%),1(30%), and 2(60%)

Primary Outcome Measures :
  1. Safety: Occurrence of study related adverse events [ Time Frame: 24 weeks ]
    Occurrence of study related adverse events as assessed by CTCAE v4.0

Secondary Outcome Measures :
  1. Effectiveness: Changes of tumor markers [ Time Frame: 24 weeks ]
    Changes of tumor markers CA-199, AFP and CEA

  2. Effectiveness: duration of in vivo survival of EGFR CART [ Time Frame: 1 year ]
    Determine duration of in vivo survival of EGFR CART

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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; -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03542799

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China, GuangGong
Geng Tian 13724395569 Tiangeng666@Aliyun.Com
Shenzhen, GuangGong, China
Contact: geng tian, DOCTOR    13724395569    tiangeng666@aliyun.com   
Sponsors and Collaborators
Shenzhen Second People's Hospital
The Pregene (ShenZhen) Biotechnology Company, Ltd.
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Responsible Party: tiangeng, Chief physician, Shenzhen Second People's Hospital
ClinicalTrials.gov Identifier: NCT03542799    
Other Study ID Numbers: Protocol. PGCAR/EGFR012
First Posted: May 31, 2018    Key Record Dates
Last Update Posted: May 31, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases