← Back to Search

CAR T-cell Therapy

CAR T Cell Therapy for Pediatric Brain Cancer

Phase 1

Waitlist Available

Research Sponsored by Seattle Children's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histologically diagnosed HER2-positive Central Nervous System (CNS) tumor

Able to tolerate apheresis, or has apheresis product available for use in manufacturing

Must not have

Diagnosis of classic diffuse intrinsic pontine glioma (DIPG)

Presence of Grade ≥ 3 cardiac dysfunction or symptomatic arrhythmia requiring intervention

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new way to treat brain tumors in children and young adults by engineering their own T cells to attack the tumor cells.

Who is the study for?

This trial is for children and young adults aged 1 to 26 with recurrent or refractory HER2-positive CNS tumors who have no standard therapy options left. They must have a CNS catheter in place, a life expectancy of at least 8 weeks, recovered from previous treatments, stable or decreasing steroid use, good organ function and lab values, not be pregnant or breastfeeding, and agree to use contraception.

What is being tested?

The study tests HER2-specific CAR T cell therapy delivered through an indwelling CNS catheter over two courses. Each course involves weekly doses for three weeks followed by one week off. The treatment aims to allow engineered T cells to directly interact with tumor cells in the brain.

What are the potential side effects?

Potential side effects may include reactions related to immune response such as inflammation around the site of infusion or within the central nervous system, general discomforts like fatigue or fever due to immune activation, and possible complications from having an indwelling catheter.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My brain tumor is HER2 positive.

Select...

I can undergo apheresis or already have an apheresis product ready for use.

Select...

It has been over a week since my last chemotherapy or biologic treatment.

Select...

It's been over 30 days or 3 half-lives since my last antibody therapy.

Select...

It has been over 30 days since my last cell infusion.

Select...

I can care for myself but may need occasional help.

Select...

My brain or spinal cord cancer has come back or isn't responding to treatment, and there's no standard treatment left.

Select...

I am between 1 and 26 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have been diagnosed with a specific brain tumor known as DIPG.

Select...

I have severe heart issues or irregular heartbeats needing treatment.

Select...

I am showing signs of a possible herniation.

Select...

I have cancer in parts of my body other than my brain.

Select...

I am currently fighting a severe infection.

Select...

I have a condition that affects my immune system or bone marrow.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Establish the feasibility, defined by the ability to produce and administer CAR T cell product, of HER2-specific CAR T cell product infusions delivered by a central nervous system (CNS) catheter into the tumor resection cavity or ventricular system

Establish the safety, defined by the adverse events, of HER2-specific CAR T cell infusions delivered by a central nervous system (CNS) catheter into the tumor resection cavity or ventricular system

Secondary study objectives

Assess the distribution of CNS-delivered HER2-specific CAR T cells within the cerebrospinal fluid (CSF) and peripheral blood

Disease

Assessment of whether HER2 expression changes in relapsed CNS tumors that were HER2 positive prior to treatment with CAR T cells

Other study objectives

Analysis of CSF for biomarkers of anti-tumor CAR T cell functional activity

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: ARM B (Ventricular System Infusion)Experimental Treatment1 Intervention

patients with either infratentorial tumors or leptomeningeal tumors for which the CAR T cells will be delivered into the fourth ventricle or lateral ventricle, respectively Intervention: HER2-specific chimeric antigen receptor (CAR) T cell

Group II: ARM A (Tumor Cavity Infusion)Experimental Treatment1 Intervention

patients with supratentorial tumors for which CAR T cells will be delivered into the tumor resection cavity Intervention: HER2-specific chimeric antigen receptor (CAR) T cell

0 / 14Eligibility criteria met