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A Study of MG7 Redirected Autologous T Cells for Advanced MG7 Positive Liver Metastases(MG7-CART)

Primary Purpose

Liver Metastases

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
MG7-CART
Sponsored by
Xijing Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Metastases

Eligibility Criteria

18 Years - 69 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • MG7 expression positive by histologically confirmed;
  • Aged between 18 and 69;
  • Persistent cancer after at least one prior standard of care chemotherapy, has no willing for surgery or cannot be suitable for surgery patients;
  • Tumor is too big to surgical resection;
  • Life expectancy greater than 4 months;
  • Satisfactory organ and bone marrow function as defined by the following: (1) creatinine <1.5mg/dl; (2) cardiac ejection fraction of >55%; (3) hemoglobin>9g/dl, bilirubin 2.0×the institution normal upper limit;
  • Without bleeding disorder or coagulation disorders;
  • Dont allergy to Radiocontrast agent;
  • Birth control;
  • Adequate venous access for apheresis, and no other contraindications for leukapheresis;
  • Voluntary informed consent is given.

Exclusion Criteria:

  • Pregnant or lactating women;
  • Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary;
  • Patients in the situation of: (1) 30 days before apheresis is still in the period of other antitumor drug observation; (2) patient dont recuperate from earlier acute adverse influence brought by any treatments accepted before;
  • Four weeks before recruit accepted radiation therapy;
  • Previously treatment with any gene therapy products;
  • Feasibility assessment during screening demonstrates<30% transduction of target lymphocytes, or insufficient expansion (<5-fold) in response to CD3/CD28 costimulation;
  • Any serious, uncontrolled diseases (including, but not limit to, unstable angina pectoris, congestive heart failure, grade III or IV cardiac disease, serious arrhythmia, liver and kidney disorders or metabolic diseases, CNS diseases);
  • Patient with severe acute hypersensitive reaction;
  • Taking part in other clinical trials;
  • Study leader considers not suitable for this tiral.

Sites / Locations

  • Xijing Hospital of Digestive DiseasesRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MG7-CART

Arm Description

A single dose of MG7-CART cells will be administered by intra-tumor injection under ultrasound guidance. The dose is 1-6x108 MG7-CAR positive T cells. The infusion will be scheduled to occur 2 days after two doses of 1.5 grams/m2 of cyclophosphamide, which will be administered according to standard procedures. The cells perfusion process would lasts 1min to 2min, and an interventional radiologist would operate the cell infusion.

Outcomes

Primary Outcome Measures

Number of patients with adverse event
adverse event is evaluated with CTCAE, version 4.0

Secondary Outcome Measures

Number of patients with tumor response
summarize tumor response by overal response rates
Detection of transferred T cells in the circulation using quantitative -PCR

Full Information

First Posted
August 7, 2016
Last Updated
August 8, 2016
Sponsor
Xijing Hospital
Collaborators
Shanghai GeneChem Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02862704
Brief Title
A Study of MG7 Redirected Autologous T Cells for Advanced MG7 Positive Liver Metastases(MG7-CART)
Official Title
An Open-label, Uncontrolled, Single-arm Pilot Study to Evaluate Safety and Efficacy of Intratumoral Delivery Mediated MG7-targeted Chimeric Antigen Receptor T Cells in Advanced MG7 Positive Liver Metastases
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Unknown status
Study Start Date
June 2016 (undefined)
Primary Completion Date
May 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xijing Hospital
Collaborators
Shanghai GeneChem Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to collect the data on the safety and potential effectiveness of intra-tumor injection of MG7-CART cells under ultrasound guidance in patients with liver metastases expressing MG7 positively.
Detailed Description
Designer T cells are prepared by PBMC which from patients by leukapheresis, and then activated and re-engineered to express chimeric antigen receptors (CARs) specific for MG7, which is a glycosylated protein of CEA. Cells are expanded in culture and returned to the participant by intra-tumor injection at the dose of (1-6)×108 CAR positive T cells. The cells perfusion process would last for 1min to 2min. The dose of 1.5 grams/m2 of cyclophosphamide will be given two days before CART cell infusion.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Metastases

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
MG7-CART
Arm Type
Experimental
Arm Description
A single dose of MG7-CART cells will be administered by intra-tumor injection under ultrasound guidance. The dose is 1-6x108 MG7-CAR positive T cells. The infusion will be scheduled to occur 2 days after two doses of 1.5 grams/m2 of cyclophosphamide, which will be administered according to standard procedures. The cells perfusion process would lasts 1min to 2min, and an interventional radiologist would operate the cell infusion.
Intervention Type
Biological
Intervention Name(s)
MG7-CART
Other Intervention Name(s)
Ultrasound-guided Intra-tumor Infusion of MG7-CART cells
Intervention Description
Ultrasound-guided intra-tumor injection as the route of T cell delivery, so that more T cells gathered at the tumor site, less migrate to the normal tissue, thereby enhancing the efficacy of anti-tumor, reducing the potential of side effects. And MG7-CART is a 2nd CAR, with MG7 as the target protein, 4-1BB as co- stimulator
Primary Outcome Measure Information:
Title
Number of patients with adverse event
Description
adverse event is evaluated with CTCAE, version 4.0
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Number of patients with tumor response
Description
summarize tumor response by overal response rates
Time Frame
8 weeks
Title
Detection of transferred T cells in the circulation using quantitative -PCR
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: MG7 expression positive by histologically confirmed; Aged between 18 and 69; Persistent cancer after at least one prior standard of care chemotherapy, has no willing for surgery or cannot be suitable for surgery patients; Tumor is too big to surgical resection; Life expectancy greater than 4 months; Satisfactory organ and bone marrow function as defined by the following: (1) creatinine <1.5mg/dl; (2) cardiac ejection fraction of >55%; (3) hemoglobin>9g/dl, bilirubin 2.0×the institution normal upper limit; Without bleeding disorder or coagulation disorders; Dont allergy to Radiocontrast agent; Birth control; Adequate venous access for apheresis, and no other contraindications for leukapheresis; Voluntary informed consent is given. Exclusion Criteria: Pregnant or lactating women; Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary; Patients in the situation of: (1) 30 days before apheresis is still in the period of other antitumor drug observation; (2) patient dont recuperate from earlier acute adverse influence brought by any treatments accepted before; Four weeks before recruit accepted radiation therapy; Previously treatment with any gene therapy products; Feasibility assessment during screening demonstrates<30% transduction of target lymphocytes, or insufficient expansion (<5-fold) in response to CD3/CD28 costimulation; Any serious, uncontrolled diseases (including, but not limit to, unstable angina pectoris, congestive heart failure, grade III or IV cardiac disease, serious arrhythmia, liver and kidney disorders or metabolic diseases, CNS diseases); Patient with severe acute hypersensitive reaction; Taking part in other clinical trials; Study leader considers not suitable for this tiral.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yongzhan Nie, Doctor
Email
yongznie@fmmu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Xuejun Yu, Master
Phone
86-18616108610
Email
yuxuejun@genechem.com.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yongzhan Nie, Doctor
Organizational Affiliation
Xijing Hospital of Digestive Diseases
Official's Role
Principal Investigator
Facility Information:
Facility Name
Xijing Hospital of Digestive Diseases
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
701032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yongzhan Nie, Doctor
Email
yongznie@fmmu.edu.cn
First Name & Middle Initial & Last Name & Degree
Xuejun Yu, Master
Phone
86-18616108610
Email
yuxuejun@genechem.com.cn

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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A Study of MG7 Redirected Autologous T Cells for Advanced MG7 Positive Liver Metastases(MG7-CART)

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