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B7-H3 CAR T Cell Therapy for Pediatric Brain Tumors

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Study Aim

This study aims to evaluate the feasibility and safety of delivering B7-H3 CAR T cell therapy directly into the brain of children with brain tumors.

What is being tested

SCRI-CARB7H3(s); B7H3-specific chimeric antigen receptor (CAR) T cel

Biological
Who is being recruted

Diffuse Intrinsic Pontine Glioma+21

+ Brain Diseases

+ Brain Neoplasms

From 1 to 26 Years
+20 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: December 2019
See protocol details

Summary

Principal SponsorSeattle Children's Hospital
Study ContactRebecca Ronsley, MD
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: December 11, 2019

Actual date on which the first participant was enrolled.

This study focuses on testing a new type of treatment for children and young adults with specific types of brain tumors, known as diffuse intrinsic pontine glioma (DIPG), diffuse midline glioma (DMG), and certain recurrent or difficult-to-treat central nervous system tumors. The treatment involves using a patient's own T cells, a type of immune cell, which are specially modified to attack cancer cells that have a specific marker called B7H3. This study aims to see if enough of these modified T cells can be made and safely given to patients directly into the brain through a special tube. This approach is important because it might offer a new way to target and treat these challenging brain tumors directly at the site. Participants in the study will undergo a process where their T cells are collected and then engineered in a lab to recognize and attack the tumor cells. The treatment is given in two courses, with the T cells being delivered into the brain either into the space where the tumor was removed or through the ventricular system, depending on the type and location of the tumor. There are three different treatment plans based on these factors. The study will closely monitor the safety of this treatment by tracking any side effects and measuring how the T cells move and interact with the body. MRI scans and other tests will be used to evaluate the treatment's effect on the tumor, and patients might continue receiving the treatment if it is well-tolerated and beneficial.

Official TitlePhase 1 Study of B7-H3-Specific CAR T Cell Locoregional Immunotherapy for Diffuse Intrinsic Pontine Glioma/Diffuse Midline Glioma and Recurrent or Refractory Pediatric Central Nervous System Tumors
NCT04185038
Principal SponsorSeattle Children's Hospital
Study ContactRebecca Ronsley, MD
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

90 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 1 to 26 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Diffuse Intrinsic Pontine GliomaBrain DiseasesBrain NeoplasmsCentral Nervous System DiseasesEpendymomaGliomaMedulloblastomaNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Germ Cell and EmbryonalNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueNervous System DiseasesNervous System NeoplasmsPinealomaInfratentorial NeoplasmsCentral Nervous System NeoplasmsNeuroectodermal TumorsNeoplasms, Complex and MixedNeuroectodermal Tumors, PrimitiveNeoplasms, NeuroepithelialRhabdoid TumorBrain Stem Neoplasms

Criteria

10 inclusion criteria required to participate
Able to tolerate apheresis, or has apheresis product available for use in manufacturing

Age ≥ 1 and ≤ 26 years

Diagnosis of refractory or recurrent CNS disease for which there is no standard therapy, or diagnosis of DIPG or DMG at any time point following completion of standard therapy

CNS reservoir catheter, such as an Ommaya or Rickham catheter

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10 exclusion criteria prevent from participating
Presence of active severe infection

Pregnant or breastfeeding

Presence of clinical and/or radiographic evidence of impending herniation

Receiving any anti-cancer agents or chemotherapy

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

4 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Patients with non-DIPG supratentorial tumors for which CAR T cells will be delivered into the tumor resection cavity

Group II

Experimental
Patients with non-DIPG either infratentorial tumors or leptomeningeal tumors for which the CAR T cells will be delivered into the ventricular system

Group III

Experimental
Patients with DIPG for whom CAR T cells will be delivered into the ventricular system

Group IV

Experimental
Patients with non-pontine DMG for whom CAR T cells will be delivered into the ventricular system

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Seattle Children's Hospital

Seattle, United StatesOpen Seattle Children's Hospital in Google Maps
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One Study Center