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This Phase 1 study examines autologous T cells engineered to express an EGFR806-specific chimeric antigen receptor (CAR) in young people aged 15 to 26 with recurrent or refractory EGFR-positive central nervous system (CNS) tumors. The CAR T cells are delivered through an indwelling catheter into the tumor resection cavity, the fourth ventricle or the lateral ventricle, depending on tumor location, as repeated infusions with intra-patient dose escalation. The primary aim is to evaluate feasibility, safety and tolerability; secondary aims include CAR T cell distribution in cerebrospinal fluid (CSF) and tumor response assessed by MRI and CSF cytology.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Inclusion Criteria: 1. Age ≥ 15 and ≤ 26 years 2. Histologically diagnosed EGFR positive Central Nervous System (CNS) tumor 3. Evidence of refractory or recurrent CNS disease for which there is no standard therapy 4. Able to tolerate apheresis or apheresis product available for use in manufacturing 5. CNS reservoir catheter, such as an Ommaya or Rickham catheter 6. Life expectancy ≥ 8 weeks 7. Lansky or Karnofsky score ≥ 60 8. If patient does not have previously obtained apheresis product, patient must have recovered from acute toxic effects of all prior chemotherapy, immunotherapy, and radiotherapy and discontinue the following prior to enrollment: 1. ≥ 7 days post last chemotherapy/biologic therapy administration 2. 3 half lives or 30 days, whichever is shorter post last dose of anti-tumor antibody therapy 3. Must be at least 30 days from most recent cellular infusion 4. All systemically administered corticosteroid treatment therapy must be stable or decreasing within 1 week prior to enrollment with maximum dexamethasone dose of 2.5 mg/m2/day. Corticosteroid physiologic replacement therapy is allowed. 9. Adequate organ function 10. Adequate laboratory values 11. Subjects of childbearing/fathering potential must agree to use highly effective contraception Exclusion Criteria: 1. Diagnosis of classic diffuse intrinsic pontine glioma (DIPG) 2. Presence of ≥ Grade 3 cardiac dysfunction or symptomatic arrhythmia requiring intervention 3. Presence of primary immunodeficiency/bone marrow failure syndrome 4. Presence of clinical and/or radiographic evidence of impending herniation 5. Presence of active malignancy other than the primary CNS tumor under study 6. Presence of active severe infection 7. Receiving any anti-cancer agents or chemotherapy 8. Pregnant or breastfeeding 9. Subject and/or authorized legal representative unwilling to provide consent/assent for participation in the 15 year follow up period 10. Presence of any condition that, in the opinion of the investigator, would prohibit the patient from undergoing treatment under this protocol