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| Diagnosis | Ependymoma | Study Status | Open |
| Phase | I |
| Age | 1 Year to 22 Years | Randomisation | NO |
| Line of treatment | Disease relapse or progression |
| Routes of Treatment Administration | Biological: HER2 Specific CAR T Cell (IV)
Phase 1 Arm: Patients receive lymphodepletion chemotherapy with cyclophosphamide IV daily on Days -7 to -6 and fludarabine IV daily on Days -5 to -1.
Patients receive HER2 CAR T cells IV on Day 0. Treatment repeats every 8 to 12 weeks for 2 additional cycles in the absence of disease progression or unacceptable toxicity.
Surgical Arm: Patients receive lymphodepletion chemotherapy with cyclophosphamide IV daily on Days -7 to -6 and fludarabine IV daily on Days -5 to -1.
Patients receive HER2 CAR T cells IV on Day 0 followed by surgical tumor resection 4-6 weeks following HER2 CAR T cell infusion. Treatment repeats every 8 to 15 weeks for 2 additional cycles in the absence of disease progression or unacceptable toxicity. |
| Last Posted Update | 2024-09-13 |
| ClinicalTrials.gov # | NCT04903080 |
International Sponsor
Pediatric Brain Tumor ConsortiumPrincipal Investigators for Canadian Sites
The Hospital for Sick Children - Dr. Joerg KruegerCentres
Study Description
This study evaluates the safety of a type of treatment called HER2 CAR T cells (short for HER2 chimeric antigen receptor T cells). In addition to looking for side effects, we will study how well this treatment works against a brain tumor called ependymoma that has come back after treatment (recurrent) or has not responded well to treatment (progressive) in children. The HER2 CAR T cells used in this trial are made from the patient's own blood.
A new gene, called the HER2 CAR, will be inserted into patient's cells to allow them to recognize a protein on the tumor called HER2. These HER2-specific CAR T cells may be able to target and kill ependymoma tumors. This research is also studying how doable it is to provide this type of CAR T cell treatment to children being treated at different hospitals.
Inclusion Criteria
- Participants must have a diagnosis of ependymoma that is has come back or progressed.
- Patient must be ≥ 1 but ≤ 22 years of age at the time of enrollment for treatment.
- Participants must be up and about for 60% of their waking hours
- Patients must have received last dose of previous chemotherapy at least 21 days before enrollment.
- Patient must meet all organ function, bone marrow function and laboratory criteria
- The patient or parent/guardian can understand the consent and is willing to sign a written informed consent document according to institutional guidelines. Age- and developmentally appropriate assent should be obtained as required by institutional guidelines.
Additional inclusion and exclusion criteria applies and will be discussed with you by the study team.
