EGFR CART Cells for Patients With Metastatic Colorectal Cancer

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

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.

Study Overview

• Status: Unknown
• Conditions: EGFR-positive Colorectal Cancer
• Intervention / Treatment: Biological: EGFR CART

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.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Shenzhen, Guangdong, China
      • Recruiting
      • The Second People's Hospital of Shenzhen
      • Contact: geng tian; Phone Number: 13724395569; Email: tiangeng666@aliyun.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Occurrence of study related adverse events as assessed by CTCAE v4.0	24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anti-tumor responses to EGFR CART cells in vivo.		24 weeks
Determine duration of in vivo survival of EGFR CART .	EGFR CART vector sequences will be determined by Q-PCR	1 year

Collaborators and Investigators

• Sponsor: Shenzhen Second People's Hospital
• Collaborators: The Beijing Pregene Science and Technology Company, Ltd.
• Investigators: Principal Investigator: geng tian, Shenzhen Second People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2017
• Primary Completion (Anticipated): September 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: May 7, 2017
• First Submitted That Met QC Criteria: May 11, 2017
• First Posted (Actual): May 15, 2017

Study Record Updates

• Last Update Posted (Actual): August 16, 2017
• Last Update Submitted That Met QC Criteria: August 13, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: FirstShenzhen02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No