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CAR T-cell Therapy

CAR T Cell Therapy for 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

Recovery from acute toxic effects of all prior chemotherapy, immunotherapy, and radiotherapy

Lansky or Karnofsky score ≥ 60

Must not have

Presence of clinical and/or radiographic evidence of impending herniation

Presence of active malignancy other than the primary CNS tumor under study

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 therapy for children and young adults with brain tumors that involves genetically modifying the patient's own T cells to attack the tumor cells.

Who is the study for?

This trial is for young people aged 15-26 with recurrent or refractory EGFR-positive CNS tumors who have a life expectancy of at least 8 weeks. They must be able to undergo apheresis, have recovered from previous treatments, and their organs must function well. Participants need an implanted CNS reservoir catheter and agree to use effective contraception.

What is being tested?

The study tests the safety and effectiveness of delivering EGFR806-specific CAR T cells directly into the brain or spinal fluid via a catheter in children and young adults with certain brain tumors. It aims to see how these cells distribute within the body, their impact on tumor response, and potential biomarkers.

What are the potential side effects?

Potential side effects may include reactions related to immune cell infusion such as fever, fatigue, headache, or neurological symptoms like confusion. Since this is an investigational therapy targeting specific cancer cells in the brain, risks are monitored closely.

Eligibility Criteria

Inclusion Criteria

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

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I have recovered from the side effects of my previous cancer treatments.

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I can care for myself but may need occasional help.

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I am between 15 and 26 years old.

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My steroid treatment dose has been stable or decreasing for the last week, and does not exceed 2.5 mg/m2/day of dexamethasone.

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My brain or spinal cord disease has not improved with treatment and there's no standard treatment left.

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My brain tumor is positive for EGFR.

Exclusion Criteria

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

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I am showing signs of a possible hernia.

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I have no active cancer other than my brain tumor.

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I am currently suffering from a severe infection.

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

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I am currently on cancer treatment.

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

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I have severe heart issues or irregular heartbeats needing treatment.

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

Feasibility: The number of successfully manufactured and infused EGFR806-specific CAR T cell product

Safety: any adverse events associated with one or multiple EGFR806-specific CAR T cell product infusions will be assessed by CTCAE v5.0.

Secondary study objectives

Cerebrospinal Fluid

Disease response: Assessment of disease response of EGFR-expressing refractory or recurrent central nervous system (CNS) tumors to EGFR806 specific CAR T cell therapy delivered directly into the CNS by cytology and radiology criteria.

Expression of target epitope: assessment of whether EGFR expression changes in relapsed CNS tumors that were EGFR positive prior to treatment with CAR T cells via immunohistochemistry on resected tissue samples.

Other study objectives

Quantitative biomarker assessment 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

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

EGFR806-specific chimeric antigen receptor (CAR) T cell

2019

Completed Phase 1

~20

0 / 13Eligibility criteria met