EGFR CART Cells for Patients With Metastatic Colorectal Cancer

EGFR-positive Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03152435
• Other study ID #: FirstShenzhen02
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: May 7, 2017
• Last updated: August 13, 2017
• Start date: June 15, 2017
• Est. completion date: December 2019

Study information

• Verified date: May 2017
• Source: Shenzhen Second People's Hospital
• Contact: geng tian
• Phone: 13724395569
• Email: tiangeng666[@]aliyun.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2019
• Est. primary completion date: September 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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;

Related Conditions & MeSH terms

• Colorectal Neoplasms
• EGFR-positive Colorectal Cancer

Intervention

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

Locations

Country	Name	City	State
China	The Second People's Hospital of Shenzhen	Shenzhen	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Shenzhen Second People's Hospital	The Beijing Pregene Science and Technology Company, Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of study related adverse events as assessed by CTCAE v4.0		24 weeks
Secondary	Anti-tumor responses to EGFR CART cells in vivo.		24 weeks
Secondary	Determine duration of in vivo survival of EGFR CART .	EGFR CART vector sequences will be determined by Q-PCR	1 year