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Keep this study
Lead
Seattle Children's Hospital
Age
0–26
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Participants age ≤ 26 years at the time of consent for study participation; the first 2 participants enrolled and treated with CAR T cells in both Arms A and B will be ≥ 15 years. and ≤ 26 years at time of consent for study participation
Recovered from significant acute toxic effects of all prior chemotherapy, immunotherapy and radiotherapy
If no apheresis product or usable T cell product is available, all chemotherapy has been discontinued ≥ 7 days prior to enrollment
If no apheresis or usable T cell product is available, all biologic therapy has been discontinued ≥ 7 days prior to enrollment
If no apheresis product or T cell product is available, all systemic corticosteroid therapy has been discontinued ≥ 7 days prior to enrollment (physiologic replacement dosing is allowed)
If no apheresis product or usable T cell product is available, at least 3 half-lives or 30 days (whichever is shorter) from time of last dose of anti-tumor directed antibody therapy (including checkpoint inhibitor) at time of enrollment
If no apheresis product or usable T cell product is available, at least 6 weeks post last dose of myeloablative therapy and autologous and/or allogeneic stem cell transplant, or non-myeloablative therapy and allogeneic stem cell transplant (all timed from stem cell infusion). Participants who receive autologous stem cell infusion following non-myeloablative therapy are eligible once all other eligibility requirements are met.
If no apheresis product or usable T cell product is available, participants who have received genetically modified cell therapy must be at least 30 days from most recent cell infusion prior to enrollment
If no apheresis product or usable T cell product is available, participants with neuroblastoma must be at least 12 weeks from I131 MIBG therapy.
Adequate organ function
Adequate laboratory values
Participant is able to tolerate apheresis (including placement of temporary apheresis catheter, if necessary), or already has an apheresis product available for use in manufacturing.
Participants 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
Receiving external beam radiation therapy at time of enrollment
Presence of active GVHD, or receiving immunosuppressive therapy for treatment or prevention of GVHD within 4 weeks prior to enrollment
Participant is pregnant or breastfeeding
Participant has presence of active severe infection
Participant has presence of any condition that, in the option of an investigator, would prohibit the participant from undergoing treatment under this protocol
Participant has primary immunodeficiency syndrome
Unwilling or unable to provide consent/assent for participation in the study and 15 year follow up period
Clareo Health | B7H3 CAR T Cell Immunotherapy for Recurrent/Refractory Solid Tumors in Children and Young Adults
