NCT02862704

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jun 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 7, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 11, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

August 11, 2016

Status Verified

August 1, 2016

Enrollment Period

11 months

First QC Date

August 7, 2016

Last Update Submit

August 8, 2016

Conditions

Liver Metastases

Outcome Measures

Primary Outcomes (1)

  • Number of patients with adverse event

    adverse event is evaluated with CTCAE, version 4.0

    6 weeks

Secondary Outcomes (2)

  • Number of patients with tumor response

    8 weeks

  • Detection of transferred T cells in the circulation using quantitative -PCR

    8 weeks

Study Arms (1)

MG7-CART

EXPERIMENTAL

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.

Biological: MG7-CART

Interventions

MG7-CARTBIOLOGICAL

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

Also known as: Ultrasound-guided Intra-tumor Infusion of MG7-CART cells
MG7-CART

Eligibility Criteria

Age18 Years - 69 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Pregnant or lactating women;
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xijing Hospital of Digestive Diseases

Xi'an, Shaanxi, 701032, China

RECRUITING

Study Officials

  • Yongzhan Nie, Doctor

    Xijing Hospital of Digestive Diseases

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yongzhan Nie, Doctor

CONTACT

yongznie@fmmu.edu.cn

Xuejun Yu, Master

CONTACT

86-18616108610yuxuejun@genechem.com.cn

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

August 7, 2016

First Posted

August 11, 2016

Study Start

June 1, 2016

Primary Completion

May 1, 2017

Study Completion

December 1, 2017

Last Updated

August 11, 2016

Record last verified: 2016-08

Locations

CN(1)