A Phase 1 Feasibility and Safety Study of Fluorescein-specific (FITC-E2)-CAR T Cells in Combination with Parenterally Administered Folate-Fluorescein (UB-TT170) For Osteogenic Sarcoma
What is the goal of the study?
The primary objectives of this study are: To identify a recommended dose regimen of UB-TT170 following administration of antiFL (FITC-E2) CAR T cells for further clinical development. To assess the safety and tolerability of cellular immunotherapy utilizing ex-vivo expanded autologous T cells genetically modified to express an antiFL(FITC-E2) CAR when administered with UB-TT170. To assess the feasibility of manufacturing antiFL (FITC-E2) CAR T cells from research participant-derived lymphocytes. To study the in vivo engraftment and persistence of transferred cells by flow cytometry and/or quantitative PCR for lentiviral vector-specific sequence. To quantify anti-tumor responses by measuring changes in tumor burden using disease-specific evaluations. To evaluate pharmacokinetics of UB-TT170 in combination with the antiFL(FITC-E2) CAR T cells.
Who can participate in the study?
The ENLIGHTen-01 study is for children and young adults who: Have evidence of refractory or recurrent/progressive osteosarcoma Are between the ages of 15 to 30 years old