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

Study acronym: IMPACT
StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary endpoint(s) modified Eligibility criteria shortened, about 6 words · Secondary endpoints: 3 to 5 · Study description shortened, about 10 wordsv7 Show 3 more changesShow less
    • Eligibility criteria shortened, about 6 words
    • Secondary endpoints: 3 to 5
    • Study description shortened, about 10 words

    See this version in full on ClinicalTrials.gov ↗

  2. Interventions: Multi-tumor antigen specific cytotoxic T lymphocytes (TSA-T) directed against proteogenomically determined personalized tumor-specific… to Group A Standard-of-Care Backbone Therapy (Drug), Group B Salvage Backbone Therapy (Radiation), Multi-tumor antigen specific cytotoxic T… Eligibility criteria expanded, about 545 words · Study description expanded, about 24 words · Study arms: 1 to 2v6 Show 3 more changesShow less
    • Eligibility criteria expanded, about 545 words
    • Study description expanded, about 24 words
    • Study arms: 1 to 2

    See this version in full on ClinicalTrials.gov ↗

  3. Re-verified, no change to tracked fieldsv5
  4. Trial status: Active, Not Recruiting to Recruiting Primary completion date: Dec 29, 2032 to Dec 29, 2030 · Start date: Jun 4, 2024 to Sep 20, 2024 · Completion date: Dec 29, 2033 to Dec 29, 2032 · 1 morev4 Show 4 more changesShow less
    • Primary completion date: Dec 29, 2032 to Dec 29, 2030
    • Start date: Jun 4, 2024 to Sep 20, 2024
    • Completion date: Dec 29, 2033 to Dec 29, 2032
    • Site details revised
  5. Trial status: Recruiting to Active, Not Recruiting Site details revised · Study description expanded, about 5 wordsv3 Show 2 more changesShow less
    • Site details revised
    • Study description expanded, about 5 words

    See this version in full on ClinicalTrials.gov ↗

  6. Trial status: Not Yet Recruiting to Recruiting Start date: Feb 5, 2024 to Jun 4, 2024 · Study sites: 0 to 1 · Secondary endpoints: 1 to 3 · 2 morev2 Show 5 more changesShow less
    • Start date: Feb 5, 2024 to Jun 4, 2024
    • Study sites: 0 to 1
    • Secondary endpoints: 1 to 3
    • Study description expanded, about 41 words
    • Eligibility criteria shortened, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06193759
Lead Sponsor Children's National Research Institute
Conditions Medulloblastoma, Childhood, Atypical Teratoid/Rhabdoid Tumor of CNS, Embryonal Tumor With Multilayered Rosettes, Pineoblastoma, Embryonal Brain Tumor Not Otherwise Specified, Ependymoma
Enrollment 12 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov