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EGFR CART Cells for Patients With Metastatic Colorectal Cancer

Primary Purpose

EGFR-positive Colorectal Cancer

Status

Unknown status

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

EGFR CART

About this trial

This is an interventional treatment trial for EGFR-positive Colorectal Cancer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 ≥ 4.0×109/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;

Sites / Locations

The Second People's Hospital of ShenzhenRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

anti-tumor response of CART-EGFR

Arm Description

Outcomes

Primary Outcome Measures

Occurrence of study related adverse events as assessed by CTCAE v4.0

Secondary Outcome Measures

Anti-tumor responses to EGFR CART cells in vivo.

Determine duration of in vivo survival of EGFR CART .

EGFR CART vector sequences will be determined by Q-PCR

Full Information

NCT ID

NCT03152435

First Posted

May 7, 2017

Last Updated

August 13, 2017

Sponsor

Shenzhen Second People's Hospital

Collaborators

The Beijing Pregene Science and Technology Company, Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT03152435

Brief Title

EGFR CART Cells for Patients With Metastatic Colorectal Cancer

Official Title

Phase I/II Study of EGFR CART Cells for Patients With Metastatic Colorectal Cancer.

Study Type

Interventional

2. Study Status

Record Verification Date

May 2017

Overall Recruitment Status

Unknown status

Study Start Date

June 15, 2017 (Actual)

Primary Completion Date

September 2019 (Anticipated)

Study Completion Date

December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Shenzhen Second People's Hospital

Collaborators

The Beijing Pregene Science and Technology Company, Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

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 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. The 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

EGFR-positive Colorectal Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

anti-tumor response of CART-EGFR

Arm Type

Experimental

Intervention Type

Biological

Intervention Name(s)

EGFR CART

Intervention Description

EGFR CART cells will be administered using a split dose on day0 (10%),1(30%), and 2(60%).

Primary Outcome Measure Information:

Title

Occurrence of study related adverse events as assessed by CTCAE v4.0

Time Frame

24 weeks

Secondary Outcome Measure Information:

Title

Anti-tumor responses to EGFR CART cells in vivo.

Time Frame

24 weeks

Title

Determine duration of in vivo survival of EGFR CART .

Description

EGFR CART vector sequences will be determined by Q-PCR

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

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 ≥ 4.0×109/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;

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

geng tian

Phone

13724395569

tiangeng666@aliyun.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

geng tian

Organizational Affiliation

Shenzhen Second People's Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Second People's Hospital of Shenzhen

City

Shenzhen

State/Province

Guangdong

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

geng tian

Phone

13724395569

tiangeng666@aliyun.com

12. IPD Sharing Statement

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EGFR CART Cells for Patients With Metastatic Colorectal Cancer

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