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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

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

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Seattle Children's HospitalLead Sponsor

302 Previous Clinical Trials

5,216,728 Total Patients Enrolled

Juliane Gust, MD, PhDStudy ChairSeattle Children's Hospital

Media Library

EGFR806-specific CAR T cell (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03638167 — Phase 1

Brain Tumor Clinical Trial 2023: EGFR806-specific CAR T cell Highlights & Side Effects. Trial Name: NCT03638167 — Phase 1

EGFR806-specific CAR T cell (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03638167 — Phase 1

Brain Tumor Research Study Groups: ARM A (Tumor Cavity Infusion), ARM B (Ventricular System Infusion)

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA issued approval of EGFR806-specific chimeric antigen receptor (CAR) T cell?

"The EGFR806-specific chimeric antigen receptor (CAR) T cell therapy has very little clinical data to support it, so its safety rating is only a 1."

Answered by AI

To what extent is enrollment being taken into the clinical trial?

"Affirmative. According to information posted on the clinicaltrials.gov website, this study is currently seeking participants and was last updated in February 2022. A total of 36 people are needed at a single medical site for enrollment into the trial."

Answered by AI

Is this experiment open to geriatric individuals?

"This trial necessitates that participants are between 1 and 26 years old, as specified in its inclusion criteria."

Answered by AI

Who meets the prerequisites for involvement in this investigation?

"This ependymoma study is recruiting 36 young people aged 1 Year to 26 who have the capacity to endure apheresis or can provide a compatible product for manufacturing. Other criteria include having gone at least 3 half lives (or 30 days) after last dose of anti-tumour antibodies, being no less than thirty days from most recent cell infusion, age between 15 and 26 years old, life expectancy above 8 weeks, and Lansky/Karnofsky score higher than 60."

Answered by AI

Is this research project currently enlisting participants?

"Indeed, a perusal of clinicaltrials.gov discloses that this research trial is open for new participants. The project was initially established on March 19th 2019 and was recently revised on February 9th 2022; 36 test subjects are being sought from one location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

EGFR806-specific CAR T Cell Locoregional Immunotherapy for EGFR-positive Recurrent or Refractory Pediatric CNS Tumors

Colleen Annesley 2019. "EGFR806-specific CAR T Cell Locoregional Immunotherapy for EGFR-positive Recurrent or Refractory Pediatric CNS Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03638167.

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