Clinical Trial Details
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NCT03500991 : HER2-specific CAR T Cell Locoregional Immunotherapy for HER2-positive Recurrent/Refractory Pediatric CNS Tumors
PhasePhase 1
AgesMin: 1 Year Max: 26 Years
Inclusion Criteria:

- First 3 enrolled subjects: age = 15 and = 26 years Subsequent subjects: age = 1 and =
26 years

- Histologically diagnosed HER2-positive Central Nervous System (CNS) tumor

- Evidence of refractory or recurrent CNS disease that has failed first-line therapy

- Willing and able to provide tumor specimens

- Able to tolerate apheresis

- Functional CNS reservoir catheter, such as an Ommaya or Rickham catheter

- Life expectancy = 8 weeks

- Lansky or Karnofsky score = 60

- Recovered from acute toxic effects of all prior chemotherapy, immunotherapy, and

- = 7 days post last chemotherapy administration

- 3 half-lives or 30 days, whichever is shorter post last dose of anti-tumor antibody

- No prior virotherapy. Prior genetically modified cell therapy is allowed if not
detectable at enrollment.

- Stable or decreasing dosing of steroid treatment for symptomatic relief from CNS
disease, with maximum dexamethasone dose of 2.5 mg/m2/day

- Adequate organ function

- Adequate laboratory values

- Patients of childbearing potential must agree to use highly effective contraception

Exclusion Criteria:

- Diagnosis of classic diffuse intrinsic pontine glioma (DIPG)

- Presence of Grade = 3 cardiac dysfunction or symptomatic arrhythmia requiring

- Presence of primary immunodeficiency/bone marrow failure syndrome

- Presence of clinical and/or radiographic evidence of impending herniation

- Presence of active malignancy other than the primary CNS tumor under study

- Presence of active severe infection

- Receiving any anti-cancer agents or chemotherapy

- Pregnant or breastfeeding

- Unwilling or unable to provide consent/assent for participation in the study and
15-year follow up period

- Presence of any condition that, in the opinion of the investigator, would prohibit the
patient from undergoing treatment under this protocol
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