Actively Recruiting
Immunotherapy for Malignant Pediatric Brain Tumors Employing Adoptive Cellular Therapy (IMPACT)
Led by Children's National Research Institute · Updated on 2026-03-10
12
Participants Needed
1
Research Sites
431 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Immunotherapy for Malignant Pediatric Brain Tumors Employing Adoptive Cellular Therapy (IMPACT)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of either newly diagnosed CNS embryonal tumors (medulloblastoma, ETMR, pineoblastoma, ATRT, embryonal tumor NOS) or recurrent ependymoma with planned or recent re-resection
- Age less than 5 years for embryonal tumors group; age greater than 1 year and less than 30 years for recurrent ependymoma group
- Availability or expectation of sufficient fresh or frozen tumor tissue for analysis
- Karnofsky or Lansky performance score of 60% or higher
- Adequate organ function including ANC ≥750/µL, ALC >500/µL, platelets ≥75K, bilirubin ≤3x ULN, AST and ALT ≤5x ULN, serum creatinine ≤1.0 mg/dL or 1.5x ULN for age, pulse oximetry >90% on room air
- Capability to provide informed consent by patient or legal guardian
- Patient size sufficient for mononuclear cell apheresis and PBSC rescue (Group A only)
- Surgical candidate for placement of Rickham reservoir
- For female patients of childbearing potential in Group B, negative pregnancy test and agreement to use contraception during and up to 6 months after treatment
- Stable neurologic exam on stable or decreasing steroid dose prior to treatment
- Presence of Rickham reservoir placed more than 7 days before TSA-T infusion
- Ability to tolerate closure of programmable VP shunts for at least 4 hours, if applicable
You will not qualify if you...
- Uncontrolled infections
- Known HIV infection
- Medulloblastoma of the SHH subtype in Group A
- Fever above 38.0°C at procurement
- Prior investigational immunotherapy within 28 days before procurement
- Inability to tolerate apheresis or placement of apheresis line
- Overly bulky tumors with herniation, significant midline shift, or brainstem involvement
- Progressive disease before subsequent TSA-T infusions
- Use of immunosuppressive T cell monoclonal antibodies within 28 days prior to TSA-T infusion
- Receiving steroids at doses greater than 0.05 mg/kg/day
- Presence of non-programmable VP shunts
AI-Screening
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Trial Site Locations
Total: 1 location
1
Children's National Hospital
Washington D.C., District of Columbia, United States, 20010
Actively Recruiting
Research Team
B
Brian Rood, MD
CONTACT
F
Fahmida Hoq, MBBS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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