Cancer – ENLIGHTen-01: A Phase I Feasibility And Safety Study of Fluorescein-Specific (FITC-E2) CAR T Cells In Combination With Parenterally Administered Folate-Fluorescein (UB-TT170) For Osteogenic Sarcoma
Condition or Therapy:
Cancer and Blood Disorders
Study Number: STUDY00003631
What is the goal of this 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 join 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
What will happen if my child takes part in this study?
In this study, researchers will take some of your blood and remove the T cells in a process called “apheresis.” The apheresis procedure may require surgery to place a catheter. Then the T cells are taken to a lab and changed to CAR T cells that recognize the flags from UB-TT170.
Once researchers think they have grown enough CAR T cells, called antiFL (FITC-E2) CAR T cells, to fight your cancer, you may get some chemotherapy to make room in your body for the new cells and then have those cells put back in your body.
A few days after you get your CAR T-cell infusion, you will start to get infusions of UB-TT170, with the dose slowly increasing (escalating) with the first few infusions until you have reached a maximum dose that you will get on a regular schedule. The UBTT170 will attach to your tumor cells and flag them so that they attract the CAR T cells. When the CAR T cells see the labeled tumor cells, they can kill the tumor cells.
You can read more about this study on clinicaltrials.gov.
Who can I contact for more information?
For more information, call 206-884-5353 or send us an email.