Able to tolerate apheresis or has apheresis product available for use in manufacturing
Life expectancy ≥ 8 weeks
Lansky or Karnofsky score ≥ 50
Recovered from significant acute toxic effects of all prior chemotherapy, immunotherapy, and radiotherapy
If no apheresis product or T cell product is available,≥ 7 days post last chemotherapy/biologic therapy administration
If no apheresis product or T cell product is available,≥ 3 half lives or 30 days, whichever is shorter, post last dose of anti-tumor antibody therapy (including check point inhibitor)
Prior genetically modified cell therapy is allowed if not detectable at enrollment.
If no apheresis product or T cell product is available,≥ 6 weeks post last dose of myeloablative therapy and allogeneic or autologous stem cell transplant
Subjects who receive autologous stem cell infusion following non-myeloablative therapy are eligible once all other eligibility requirements are met
If no apheresis product or T cell product is available,≥ 7 days post last systemic corticosteroid therapy (physiologic replacement dosing is allowed)
If no apheresis product or T cell product is available, subjects with neuroblastoma must be ≥ 12 weeks from I131 MIBG therapy.
Adequate organ function
Adequate laboratory values
Patients of childbearing potential must agree to use highly effective contraception
You may not be if
Presence of active malignancy other than primary malignant solid tumor diagnosis
Current relevant CNS pathology
Presence of active GVHD, or receiving immunosuppressive therapy for treatment or prevention of GVHD within 4 weeks prior to enrollment
Presence of active severe infection
Presence of primary immunodeficiency syndrome
Receiving external beam radiation therapy at time of enrollment
Receiving any anti-cancer agents or chemotherapy
Pregnant or breastfeeding
Unwilling 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
Clareo Health | EGFR806 CAR T Cell Immunotherapy for Recurrent/Refractory Solid Tumors in Children and Young Adults
