A Phase I/IIa, Open Label, Dual Cohort, Triple Center Clinical Trial Evaluating the Safety and Efficacy of Autologous T Cells Expressing Enhanced TCRs Specific for MAGE-A3/A6/B18 or NYESO-1/LAGE in Patients With Recurrent or Treatment Refractory Ovarian Cancer
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
NCI CTC V.4 Adverse Events related to study treatment greater than or equal to Grade 3
This will evaluate safety of autologous genetically modified T cells transduced to express the high affinity MAGE-A3a3a TCR in HLA-A101 subjects, and the high affinity NY-ESO-1c259 TCR in HLA-A201 subjects.
Kunle Odunsi, MD, PhD
Roswell Park Cancer Institute
United States: Food and Drug Administration
|Roswell Park Cancer Institute||Buffalo, New York 14263|