Last updated on March 2020

EGFR806-specific CAR T Cell Locoregional Immunotherapy for EGFR-positive Recurrent or Refractory Pediatric CNS Tumors


Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Brain Cancer | Choroid Plexus Carcinoma | Neurectoderma | Primitive neuroectodermal tumor | Neuroectodermal Tumor | Malignant neoplasm of brain | Medulloblastoma | Central Nervous System Tumor | Gliomas | Pediatric | Germ Cell Tumors | Glioma | Atypical Teratoid Rhabdoid Tumor | Ependymoma | Brain Tumor | Brain Tumor (Pediatric) | Pinealoma | Germ cell tumor
  • Age: Between 1 - 26 Years
  • Gender: Male or Female

Inclusion Criteria:

  • First 3 enrolled subjects: age 15 and 26 years Subsequent subjects: age 1 and 26 years
  • Histologically diagnosed EGFR positive Central Nervous System (CNS) tumor
  • Evidence of refractory or recurrent CNS disease that has failed first-line therapy
  • Able to tolerate apheresis or apheresis product available for use in manufacturing
  • 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 radiotherapy
  • 7 days post last chemotherapy administration
  • 3 half lives or 30 days, whichever is shorter post last dose of anti-tumor antibody therapy
  • 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
  • Subjects of childbearing/fathering potential must agree to use highly effective contraception
  • Subject and/or authorized legal representative signed a written consent

Exclusion Criteria:

  • Diagnosis of classic diffuse intrinsic pontine glioma (DIPG)
  • Presence of Grade 3 cardiac dysfunction or symptomatic arrhythmia requiring intervention
  • 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
  • Subject and/or authorized legal representative unwilling to provide consent/assent for participation in the 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

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


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