EGFR806 CAR T Cell Immunotherapy for Recurrent/Refractory Solid Tumors in Children and Young Adults

Launched by SEATTLE CHILDREN'S HOSPITAL · Aug 6, 2018

Keywords

ClinConnect Summary

This clinical trial is looking at a new type of treatment called EGFR806 CAR T Cell Immunotherapy for children and young adults with certain types of solid tumors that have returned or didn’t respond to previous treatments. The goal is to see how safe and effective this therapy is. In this study, doctors will take T cells (a type of immune cell) from the participant's blood and modify them in the lab so they can better target and attack the cancer cells. Participants will either receive these modified T cells alone or along with another type that helps boost their effectiveness. The study aims to understand how well these modified cells work, how long they stay in the body, and what side effects they might cause.

To be eligible for this trial, participants should be between the ages of 1 and 30 and have a specific type of solid tumor that shows certain markers. They must also be able to handle a procedure to collect their blood cells and have a life expectancy of at least 8 weeks. Before joining, they should have recovered from any severe side effects from past treatments and meet other health criteria. Participants can expect to receive a single infusion of the modified T cells and will be closely monitored for any side effects or signs of improvement during the trial. It’s important to note that while this study is hopeful, it is still in the early stages of testing.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • First 2 subjects enrolled and treated in both Arm A and Arm B: age ≥ 15 and ≤ 30 years
• • Subsequent subjects: age ≥ 1 and ≤30years
• • Histologically diagnosed malignant, non-CNS solid tumor expressing EGFR
• • Evidence of refractory or recurrent disease
• • 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
• Exclusion Criteria:
• • 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