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

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
Children's National Research Institute
Study ID
NCT06193759
Phase
PHASE1
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
1 Year - 30 Years
Healthy Volunteers
Not accepted

Interventions

  • Multi-tumor antigen specific cytotoxic T lymphocytes (TSA-T) directed against proteogenomically determined personalized tumor-specific antigens (TSA) — BIOLOGICAL
    Participants in this study will receive TSA-T after completion of standard-of-care treatment.
  • Group A Standard-of-Care Backbone Therapy — DRUG
    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).
  • Group B Salvage Backbone Therapy — RADIATION
    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.

Study Details

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.

Key Dates

Start date
Sep 20, 2024
Status verified
Mar 2026
Primary completion
Dec 29, 2030
Completion
Dec 29, 2032

Study Design

Enrollment
12 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Embryonal brain tumors
    Children younger than 5 years of age with newly diagnosed embryonal brain tumors - including medulloblastoma (MB), atypical teratoid/rhabdoid tumor (ATRT), embryonal tumor with multilayered rosettes (ETMR), and embryonal brain tumor not otherwise specified (NOS).
  • Experimental: Ependymoma
    Children, adolescents and young adults greater than 1 year and less than 30 years of age with recurrent ependymoma

Primary Outcome Measure

Grade ≥3 infusion-related adverse event [ Time Frame: 42 days of the first TSA-T infusion ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Children's National HospitalWashington D.C.District of Columbia20010
Brian Rood, MD
[email protected]
202-476-2314

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By research site
Children's National Hospital· Washington D.C., DC

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