NCT01694472

Clinical Safety and Preliminary Efficacy of MAGE-A4 TCR Gene-Modified T Cells to Treat Malignant Tumors

Phase 1 Study of MAGE-A4 TCR Gene-Modified T Cells to Treat Malignant Tumors

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Tianjin Medical University Cancer Institute and Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the clinical safety and preliminary efficacy of MAGE-A4 TCR Gene-Modified T lymphocytes in the treatment of malignant solid tumor patients, such as malignant melanoma and lung cancer.

Conditions

• Malignant Solid Tumors

Interventions

Type	Name	Description
BIOLOGICAL	MAGE-A4 TCR Gene-Modified T Cells	The study consists of a 2-dose escalation scheme, and the patient receives twice in each dose. The starting dose is 1-3 x 10\^9 cells of each TCR gene-modified cells and the second one is 3-8 x 10\^9 cells of each TCR gene-modified cells. Two weeks after the first infusion the patient receives the same dose again, followed by infusions of IL-2 for 5 days. Thereafter, the patient receives peptide vaccinations on days 21 and 28.

Timeline

• Start date: 2012-07-01
• Primary completion: 2016-11-01
• Completion: 2016-12-01
• First posted: 2012-09-27
• Last updated: 2015-12-22

Locations

1 site across 1 country: China