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NCT06193759 · ClinicalTrials.gov registry record · Phase 1
Immunotherapy for Malignant Pediatric Brain Tumors Employing Adoptive Cellular Therapy (IMPACT)
A Phase 1 study of Ependymoma and Pineoblastoma, sponsored by Children's National Research Institute.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
- 1
- Study location
NCT06193759: Recruiting Phase 1 study of Ependymoma and Pineoblastoma, sponsored by Children's National Research Institute.
NCT06193759 is a Phase 1 study of Ependymoma and Pineoblastoma that is actively recruiting participants, run by Children's National Research Institute. The registered enrollment target is 12 participants, below the 104-participant average among 20 other Ependymoma trials with a reported enrollment target (88% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06193759, a Phase 1 study of Ependymoma and Pineoblastoma, is actively recruiting participants, sponsored by Children's National Research Institute.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
The safety endpoint will be assessed by monitoring for incidence of DLTs-defined as any of the below events occurring within 42 days following a participant's first TSA-T infusion (per CTCAE v. 6.0): * Grade ≥3 infusion-related adverse event. * Grade ≥4 non-hematologic adverse event that is not due to the patient's underlying malignancy or chemotherapy related co-morbidities. * Grade ≥3 pneumonitis, uveitis. * Grade ≥3 toxicities that are attributed to TSA-T (possibly, probably or definitely TS
Conditions Studied
Interventions
- BIOLOGICAL Multi-tumor antigen specific cytotoxic T lymphocytes (TSA-T) directed against proteogenomically determined personalized tumor-specific antigens (TSA)
- DRUG Group A Standard-of-Care Backbone Therapy
- RADIATION Group B Salvage Backbone Therapy
Study Locations (1)
District of Columbia
- Children's National Hospital - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2024-09-20 |
| Est. Completion | 2032-12-29 |
| Phase | Phase 1 |
What NCT06193759 shows while recruiting
NCT06193759 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 104-participant average among 20 other Ependymoma trials with a reported enrollment target (88% lower).
The record links to 6 conditions, with Ependymoma appearing as the primary indexed condition, and to 3 interventions - of which Multi-tumor antigen specific cytotoxic T lymphocytes (TSA-T) directed against proteogenomically determined personalized tumor-specific antigens (TSA) is the first listed.
NCT06193759 reports a single indexed study location in District of Columbia.
Frequently Asked Questions
What is clinical trial NCT06193759 about?
NCT06193759 is a clinical study titled "Immunotherapy for Malignant Pediatric Brain Tumors Employing Adoptive Cellular Therapy (IMPACT)". 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 ...
What is the current status of trial NCT06193759?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2024-09-20. Estimated completion is 2032-12-29.
What conditions does trial NCT06193759 study?
This clinical trial studies the following conditions: Ependymoma, Pineoblastoma, Embryonal Tumor With Multilayered Rosettes, Medulloblastoma, Childhood, Atypical Teratoid/Rhabdoid Tumor of CNS.
What interventions are being tested in trial NCT06193759?
The interventions under investigation include: Multi-tumor antigen specific cytotoxic T lymphocytes (TSA-T) directed against proteogenomically determined personalized tumor-specific antigens (TSA) (BIOLOGICAL), Group A Standard-of-Care Backbone Therapy (DRUG), Group B Salvage Backbone Therapy (RADIATION).
Who is sponsoring clinical trial NCT06193759?
This trial is sponsored by Children's National Research Institute, which has 92 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06193759 being conducted?
This trial has 1 study location across District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT06193759's enrollment target sits among peer trials
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participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Ependymoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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