Clinical Trials Search
Clinical Trial 18522
Study Type: Treatment
Phase of Study: Phase I/II
- Benjamin Creelan
A Phase I Dose Escalation Open Label Clinical Trial Evaluating the Safety and Efficacy of MAGE-A10c796T in Subjects with Stage IIIb or Stage IV Non-Small Cell Lung Cancer (NSCLC)
The purpose of this study is to test the safety of genetically changed T cells, an investigational therapy, and find out what effects, if any, they have in participants with lung cancer. T cells are a natural type of immune cell in the blood that can be changed in a laboratory with the aim to destroy some types of cancer cells. The changed T cells used in this study will be the participant¿s own T cells that have been genetically changed with the aim of attacking and destroying cancer cells.
Primary: To evaluate the safety and tolerability of MAGE-A10c796T autologous genetically modified T cells in HLA-A*0201 and HLA-A*0206 positive subjects with MAGE- A10 positive advanced NSCLC. Secondary: 1- To evaluate the efficacy of MAGE-A10c796T. 2- To measure persistence of genetically modified cells in the body. 3- To evaluate the phenotype and functionality of genetically modified cells isolated from peripheral blood or tumor post infusion. 4- To evaluate MAGE-A10 expression in tumor tissue, before and after treatment, and correlate with clinical response to treatment.