Phase 1 Trial of Autologous HER2-specific CAR T cells in Pediatric Patients with Refractory or Recurrent Ependymoma
Primary Objective
The research is studying how easy it is to provide CAR-T cells to children who may have treatment at different hospitals. We are using CAR-T cells in this study because there is some evidence to believe it may work against cancers like yours.
Description
Because of your cancer diagnosis, we previously received your permission to make HER2 CAR T cells from the blood you provided. Now, because we have successfully made your HER2 CAR T cells, you will be asked to enroll on the Phase 1 treatment study. The treatment for the Phase 1 study will be given in two parts called (1) Lymphodepletion and (2) HER2 CAR T cell Infusion, which are described in detail in this document. Lymphodepletion consists of treatment with two chemotherapy (anti-cancer) drugs called cyclophosphamide and fludarabine, although in this study we are not using them to treat your cancer. In this study, lymphodepletion is being used to temporarily clear away some of the other immune cells in your blood to make room for the CAR T cells to multiply after we give them. This treatment will be given up to three times. The treatment on this study takes up to one year.
Details
Locations
Childrens Hospital Colorado
Principal Investigator
Holly Lindsay
Study ID
Protocol Number: 21-5057
More information available at ClinicalTrials.gov: NCT04903080
Categories
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