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

NCT ID: NCT02862704

Last Updated: 2016-08-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2017-12-31

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.

Conditions

Liver Metastases

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MG7-CART

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.

Group Type: EXPERIMENTAL

MG7-CART

Intervention Type: BIOLOGICAL

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

Interventions

MG7-CART

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

Intervention Type: BIOLOGICAL

Other Intervention Names

Ultrasound-guided Intra-tumor Infusion of MG7-CART cells

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 69 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai GeneChem Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Xijing Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yongzhan Nie, Doctor

Role: PRINCIPAL_INVESTIGATOR

Xijing Hospital of Digestive Diseases

Locations

Xijing Hospital of Digestive Diseases

Xi'an, Shaanxi, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yongzhan Nie, Doctor

Role: CONTACT

yongznie@fmmu.edu.cn

Xuejun Yu, Master

Role: CONTACT

yuxuejun@genechem.com.cn

86-18616108610

Facility Contacts

Yongzhan Nie, Doctor

Role: primary

yongznie@fmmu.edu.cn

Xuejun Yu, Master

Role: backup

yuxuejun@genechem.com.cn

86-18616108610

Other Identifiers

MG7-CART

Identifier Type: -

Identifier Source: org_study_id