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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

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My brain tumor is HER2 positive.

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

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

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

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

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I can care for myself but may need occasional help.

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

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I am between 1 and 26 years old.

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

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 outcome measures

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 outcome measures

Analysis of CSF for biomarkers 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 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 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

Seattle Children's HospitalLead Sponsor

301 Previous Clinical Trials

5,216,967 Total Patients Enrolled

1 Trials studying Pinealoblastoma

11 Patients Enrolled for Pinealoblastoma

Nicholas Vitanza, MDStudy ChairSeattle Children's Hospital

Media Library

HER2-specific CAR T Cell Locoregional Immunotherapy (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03500991 — Phase 1

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

Pinealoblastoma Clinical Trial 2023: HER2-specific CAR T Cell Locoregional Immunotherapy Highlights & Side Effects. Trial Name: NCT03500991 — Phase 1

HER2-specific CAR T Cell Locoregional Immunotherapy (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03500991 — Phase 1

Frequently Asked Questions

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

How many participants are partaking in this investigation?

"Affirmative. The information posted on clinicaltrials.gov suggest that this experiment is currently recruiting patients, with the first posting taking place on July 26th 2018 and the last edit occurring February 10th 2022. As of now, 48 participants are needed at a single site to complete the study."

Answered by AI

Do I meet the criteria necessary for participation in this research?

"Eligible candidates for this medical trial have to be between 1 year and 26 years old, as well as presenting with medulloblastoma. The aim is to enlist 48 participants through the duration of the study."

Answered by AI

Has the FDA sanctioned usage of HER2-specific chimeric antigen receptor (CAR) T cell therapy?

"Due to the limited amount of clinical data on HER2-specific chimeric antigen receptor (CAR) T cell safety and efficacy, our team rates this intervention a 1."

Answered by AI

Is there still availability for participants in this trial?

"Affirmative. The information available on clinicaltrials.gov verifies that this medical study is presently looking for participants - the trial was first posted in July 2018 and last updated in February 2022, with 48 patients being sought from a single location."

Answered by AI

Is the age criterion for participating in this research project restricted to those over 18 years of age?

"This clinical trial is open to participants between 1 Year and 26 years old. On the other hand, there are 478 trials available for young people below 18, along with 2460 studies that target seniors over 65."

Answered by AI

Recent research and studies

Nature MedicineJournal

Locoregional Infusion of Her2-specific CAR T Cells in Children and Young Adults with Recurrent or Refractory CNS Tumors: An Interim Analysis

Vitanza, Nicholas A., Adam J. Johnson, Ashley L. Wilson, Christopher Brown, Jason K. Yokoyama, Annette Künkele, Cindy A. Chang, et al.. 2021. “Locoregional Infusion of Her2-specific CAR T Cells in Children and Young Adults with Recurrent or Refractory CNS Tumors: An Interim Analysis”. Nature Medicine. Springer Science and Business Media LLC. doi:10.1038/s41591-021-01404-8.

clinicaltrials.govStudy

HER2-specific CAR T Cell Locoregional Immunotherapy for HER2-positive Recurrent/Refractory Pediatric CNS Tumors

Colleen Annesley 2018. "HER2-specific CAR T Cell Locoregional Immunotherapy for HER2-positive Recurrent/Refractory Pediatric CNS Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03500991.

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