NCT02862704

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

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

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Xijing Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 69 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
BIOLOGICAL	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

Timeline

• Start date: 2016-06-01
• Primary completion: 2017-05-01
• Completion: 2017-12-01
• First posted: 2016-08-11
• Last updated: 2016-08-11

Locations

1 site across 1 country: China