CAR T cell therapy for children and young adults with solid tumors
Phase I Study of EGFR806 CAR T Cell Immunotherapy for Recurrent/Refractory Solid Tumors in Children and Young Adults
This study is testing a new type of immune therapy using modified T cells to see if it can help children and young adults with tough-to-treat solid tumors.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 44 (estimated) |
| Ages | 1 Year to 30 Years |
| Sex | All |
| Sponsor | Seattle Children's Hospital Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, radiation, cetuximab, trastuzumab, CAR T, chimeric antigen receptor |
| Locations | 1 site (Seattle, Washington) |
| Trial ID | NCT03618381 on ClinicalTrials.gov |
What this trial studies
This phase I, open-label study evaluates the safety and efficacy of EGFR806 CAR T cell immunotherapy in pediatric and young adult patients with recurrent or refractory non-CNS solid tumors. Participants will receive genetically modified T cells that target tumors expressing the EGFR protein. The study includes two arms: one receiving EGFR-specific CAR T cells and another receiving CAR T cells targeting both EGFR and CD19. The goal is to assess the feasibility of this innovative treatment approach in this patient population.
Who should consider this trial
Good fit: Ideal candidates are pediatric and young adult patients aged 1 to 30 with recurrent or refractory non-CNS solid tumors expressing EGFR.
Not a fit: Patients with CNS tumors or those who do not express the EGFR protein may not benefit from this therapy.
Why it matters
Potential benefit: If successful, this therapy could provide a new treatment option for children and young adults with difficult-to-treat solid tumors.
How similar studies have performed: Other studies using CAR T cell therapies have shown promise, particularly in hematological malignancies, but this specific approach in solid tumors is still novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Seattle, Washington
- Seattle Children's Hospital — Seattle, Washington, United States (Recruiting)
Study contacts
- Study coordinator: Katie Albert, MD
- Email: immunotherapy@seattlechildrens.org
- Phone: 206-987-2106
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.