EGFR CART Cells for Patients With Metastatic Colorectal Cancer

NCT03152435 | Unknown Phase 1

• 1 other identifier: FirstShenzhen02
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

EGFR-positive Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

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

  24 weeks

Secondary Outcomes (2)

• Anti-tumor responses to EGFR CART cells in vivo.

  24 weeks

• Determine duration of in vivo survival of EGFR CART .

  1 year

Study Arms (1)

anti-tumor response of CART-EGFR

EXPERIMENTAL

Biological: EGFR CART

Interventions

EGFR CART BIOLOGICAL

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

anti-tumor response of CART-EGFR

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Patients must be 18 years to 70 years;
• \. Clinical diagnosis of EGFR positive for patients with metastatic colorectal cancer;
• \. Patients must have a KPS of \>80, expected survival \> 3 months;
• \. Patients must have at least one measurable lesions;
• \. Recently did not use glucocorticoid;
• \. 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，
• \. Patients must have a good heart function (LVEF\>50%) ;
• \. 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；
• \. Patients must be willing to sign an informed consent.

You may not qualify if:

• \. Patients with other cancer history;
• \. Patients allergic to cetuximab;
• \. Patients with severe bronchitis, bronchial asthma, or severs pneumonia;
• \. Patients with uncontrolled active infections (bacteria, viruses or fungi infection) ;
• \. Patients with acute and chronic GVHD (graft versus host disease)
• \. Patients with severe autoimmune diseases;
• \. Previously treatment with T cell inhibitors (cyclophosphamide, FK506);
• \. Patients with active hepatitis B or hepatitis C infection, HIV infection, syphilis serology reaction positive;
• \. Patients who are participating or participated any other clinical research in the past 1 months;
• \. Pregnant and/or lactating women will be excluded;

Sponsors & Collaborators

• Shenzhen Second People's Hospital: lead
• The Beijing Pregene Science and Technology Company, Ltd.: collaborator

Study Sites (1)

The Second People's Hospital of Shenzhen

Shenzhen, Guangdong, China

RECRUITING

Study Officials

• geng tian

  Shenzhen Second People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

geng tian

CONTACT

13724395569; tiangeng666@aliyun.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2017
• First Posted: May 15, 2017
• Study Start: June 15, 2017
• Primary Completion: September 1, 2019
• Study Completion: December 1, 2019
• Last Updated: August 16, 2017

Record last verified: 2017-05

Locations

CN (1)