RecruitingPhase 1NCT06193759

Immunotherapy for Malignant Pediatric Brain Tumors Employing Adoptive Cellular Therapy (IMPACT)

Sponsor

Children's National Research Institute

Enrollment

12 participants

Start Date

Sep 20, 2024

Study Type

INTERVENTIONAL

Conditions

Pineoblastoma Embryonal Tumor With Multilayered Rosettes Ependymoma Medulloblastoma, Childhood Atypical Teratoid/Rhabdoid Tumor of CNS Embryonal Brain Tumor Not Otherwise Specified

Summary

This is an open-label phase 1 safety and feasibility study that will employ multi-tumor antigen specific cytotoxic T lymphocytes (TSA-T) directed against proteogenomically determined personalized tumor-specific antigens (TSA) derived from a patient's primary brain tumor tissues. Young patients with embryonal central nervous system (CNS) malignancies typically are unable to receive irradiation due to significant adverse effects and are treated with intensive chemotherapy followed by autologous stem cell rescue; however, despite intensive therapy, many of these patients relapse. In this study, individualized TSA-T cells will be generated against proteogenomically determined tumor-specific antigens after standard of care treatment in children less than 5 years of age with embryonal brain tumors. Correlative biological studies will measure clinical anti-tumor, immunological and biomarker effects.

Eligibility

Min Age: 1 YearMax Age: 30 Years

Plain Language Summary

Simplified for easier understanding

This study (IMPACT) is testing a personalized immune cell therapy made from a child's own tumor tissue for two groups: very young children (under 5) newly diagnosed with aggressive brain tumors, and older children/young adults with recurring ependymoma (a type of brain tumor). **Your child may be eligible if...** - Group A: They are under 5 years old and newly diagnosed with an aggressive brain tumor (medulloblastoma, ETMR, pineoblastoma, AT/RT, or NOS embryonal tumor) with sufficient tumor tissue available - Group B: They are between 1 and 30 years old with a recurrent ependymoma that is being surgically re-removed - Their general health and organ function meet study requirements (Karnofsky/Lansky score ≥60%) **Your child may NOT be eligible if...** - Sufficient tumor tissue cannot be collected - Their organ function (blood counts, liver, kidneys) does not meet minimum thresholds - They are pregnant (if applicable) Talk to your doctor to see if this trial is right for your child.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALMulti-tumor antigen specific cytotoxic T lymphocytes (TSA-T) directed against proteogenomically determined personalized tumor-specific antigens (TSA)

Participants in this study will receive TSA-T after completion of standard-of-care treatment.

DRUGGroup A Standard-of-Care Backbone Therapy

Patients will undergo surgical resection, then be treated with standard-of-care therapy as required, which may include up to 3 induction chemotherapy cycles (vincristine, cyclophosphamide, cisplatin, etoposide with or without methotrexate) and up to 3 consolidation cycles (carboplatin and thiotepa, each followed by an infusion of autologous peripheral blood stem cells).

RADIATIONGroup B Salvage Backbone Therapy

Patients will undergo surgical re-resection - aiming for gross total resection when feasible - followed by re-irradiation. Re-irradiation may be delivered as a conventional fractionated course, hypofractionated stereotactic radiotherapy, or proton therapy.