EGFR-IL12-CART Cells for Patients With Metastatic Colorectal Cancer

NCT03542799 | Unknown Phase 1

• 1 other identifier: Protocol. PGCAR/EGFR012
• 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 -IL12 -CART) cells in metastatic patients with colorectal cancer.

Conditions

Metastatic Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Safety: Occurrence of study related adverse events

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

  24 weeks

Secondary Outcomes (2)

• Effectiveness: Changes of tumor markers

  24 weeks

• Effectiveness: duration of in vivo survival of EGFR CART

  1 year

Study Arms (1)

3

EXPERIMENTAL

anti-tumor response of EGFR IL12 CART

Biological: EGFR IL12 CART

Interventions

EGFR IL12 CART BIOLOGICAL

EGFR IL12 CART cells will be administered using a split dose on day0 (10%),1(30%), and 2(60%)

3

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 ≥ 3.0×109/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 Pregene (ShenZhen) Biotechnology Company, Ltd.: collaborator

Study Sites (1)

Geng Tian 13724395569 Tiangeng666@Aliyun.Com

Shenzhen, GuangGong, China

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: May 18, 2018
• First Posted: May 31, 2018
• Study Start: May 22, 2018
• Primary Completion: May 23, 2020
• Study Completion: May 23, 2021
• Last Updated: May 31, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)