Back to search results

Immunotherapy for Pediatric Brain Tumors (IMPACT) Study

This study, called IMPACT, is testing a new type of immunotherapy called multi-tumor antigen specific cytotoxic T lymphocytes (TSA-T) for children, adolescents, and young adults with certain high-risk brain tumors. These tumors include medulloblastoma, atypical teratoid/rhabdoid tumor, embryonal tumor with multilayered rosettes, pineoblastoma, and other embryonal brain tumors, as well as recurrent ependymoma. TSA-T cells are personalized treatments made from your own tumor tissue to specifically target cancer cells. You would receive TSA-T after completing your standard cancer treatment. This study aims to find out if TSA-T is safe and what dose works best. It is currently unclear if the study is actively enrolling, and it plans to include 12 participants.

Study design
This is an open-label Phase 1 study, meaning both you and your doctors will know what treatment you are receiving. It plans to enroll 12 participants.
What's involved
You would receive TSA-T infusions at Children's National Hospital after completing your standard cancer treatment. Safety will be checked for 42 days after the first TSA-T infusion.
Compensation
Not stated in the trial record.
Follow-up
The study will follow participants for up to 5 years after the first TSA-T cell infusion to assess the feasibility of identifying tumor-specific antigens.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06193759

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

Recruiting
PHASE1Ages 1–30InterventionalTreatment
Children's National Research Institute
~12 participants
Updated 2026-06-17 on ClinicalTrials.gov
What's tested:Multi-tumor antigen specific cytotoxic T lymphocytes (TSA-T) directed against proteogenomically determined personalized tumor-specific antigens (TSA)Group A Standard-of-Care Backbone TherapyGroup B Salvage Backbone Therapy

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To evaluate the safety of TSA-T in children, adolescents, and young adults with high-risk CNS embryonal tumors and recurrent ependymomas. Safety will be evaluated by the incidence of dose limiting toxicities (DLTs).
Measured over 42 days of the first TSA-T infusion
+3 more outcomes measured

Conditions

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

Explore related trials

Atypical Teratoid/Rhabdoid TumorBrain Embryonal Tumor, Not Otherwise SpecifiedEmbryonal Tumor with Multilayered RosettesEpendymomaMedulloblastomaPineoblastoma

Where it's being run

1 sites across 1 states
District of Columbia1

Study leadership

  • Brian Rood, MD · PRINCIPAL_INVESTIGATOR · Children's National Research Institute

Who to contact

Brian Rood, MD
[email protected]
2024762314
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

Group A: New diagnosis of CNS embryonal tumors: medulloblastoma, embryonal tumor with multilayered rosettes, pineoblastoma, atypical teratoid/rhabdoid tumor, and embryonal tumor, not otherwise specified (NOS).
Group B: Radiographic evidence consistent with recurrent ependymoma, with planned or recent re-resection. 2. Age:
Group A: \<5 years of age at enrollment
Group B: \>1 year and \<30 years of age at enrollment 3. Tissue:
Group A: N/A
Group B: For female of childbearing potential, must have negative pregnancy test.
Group A: N/A
Group B: For female of childbearing potential (if applicable), must have negative pregnancy test.

What this trial measures

  • To evaluate the safety of TSA-T in children, adolescents, and young adults with high-risk CNS embryonal tumors and recurrent ependymomas. Safety will be evaluated by the incidence of dose limiting toxicities (DLTs).42 days of the first TSA-T infusion

    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 TSA-T related). * Unexpected toxicity of grade ≥3 attributed to the infusion of TSA-T (possibly, probably or definitely TSA-T related).

  • To estimate the maximum-tolerated dose (MTD) of intracerebroventricularly-administered TSA-T in children, adolescents and young adults with high-risk CNS embryonal tumors and recurrent ependymoma.42 days of the first TSA-T infusion

    The MTD will be estimated adaptively throughout the trial using Bayesian optimal interval (BOIN) design, based on incidence of DLTs. After trial completion, the final maximum tolerated dose regimen (MTDR) will be selected using isotonic regression of pooled safety data from Groups A and B.

  • Feasibility of TSA identificationUp to 5 years after the first TSA-T cell infusion

    The number of TSA identified for each tumor will be measured. The endpoint will be the number of patients with at least 2 TSA peptides identified.

  • Feasibility of TSA-T cell generationAt start of SOC/Salvage therapy until start of TSA-T cell treatment (up to 24 weeks)

    The time from the acquisition of tissue to the availability of manufactured TSA-T products, measured in comparison to the length of the SOC therapy regimen/s preceding the infusion (\~12-24 weeks).