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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
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 belowSelect...
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:Select...
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
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 outcome measures
Quantitative biomarker assessment of anti tumor CAR T cell functional activity
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
Find a Location
Who is running the clinical trial?
Seattle Children's HospitalLead Sponsor
307 Previous Clinical Trials
5,218,398 Total Patients Enrolled
5 Trials studying Germ Cell Tumors
304 Patients Enrolled for Germ Cell Tumors
Juliane Gust, MD, PhDStudy ChairSeattle Children's Hospital
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can undergo apheresis or have apheresis products ready for use.I have recovered from the side effects of my previous cancer treatments.My organs are working well.I can care for myself but may need occasional help.I am showing signs of a possible hernia.I have no active cancer other than my brain tumor.I am currently suffering from a severe infection.You have a CNS reservoir catheter, like an Ommaya or Rickham catheter.You are expected to live for at least 8 more weeks.I am between 15 and 26 years old.Your lab test results are within the normal range.I have been diagnosed with a specific brain tumor known as DIPG.I am currently on cancer treatment.I have a condition that affects my immune system or bone marrow.I have severe heart issues or irregular heartbeats needing treatment.My steroid treatment dose has been stable or decreasing for the last week, and does not exceed 2.5 mg/m2/day of dexamethasone.My brain or spinal cord disease has not improved with treatment and there's no standard treatment left.My brain tumor is positive for EGFR.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: ARM A (Tumor Cavity Infusion)
- Group 2: ARM B (Ventricular System Infusion)
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