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CAR T-cell Therapy

CAR T Cell Therapy for Pediatric Brain Cancer

Phase 1

Recruiting

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

Age ≥ 1 and ≤ 26 years

Diagnosis of refractory or recurrent CNS disease for which there is no standard therapy, or diagnosis of DIPG or DMG at any time point following completion of standard therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 7 months

Awards & highlights

Study Summary

This trial is testing a new cancer treatment for children and young adults with brain tumors. T cells are collected from the patient and engineered to create a CAR T cell that targets B7H3-expressing tumor cells. The patient is then administered the CAR T cells via an indwelling catheter, and the treatment is given in two courses. The hypothesis is that this new treatment is safe and effective.

Who is the study for?

This trial is for children and young adults aged 1 to 26 with specific brain tumors like DIPG, DMG, or other recurrent CNS tumors without standard treatment options. They must be able to undergo apheresis (a procedure to collect T cells), have a catheter in their CNS for drug delivery, expect to live at least 8 weeks, have decent performance status scores (Lansky/Karnofsky ≥60), recovered from prior treatments, stable on low-dose steroids, good organ function and lab values.Check my eligibility

What is being tested?

The study tests B7-H3-specific CAR T cell therapy delivered directly into the brain or ventricular system through an indwelling catheter. It's divided into three arms based on tumor location/type. Patients receive two courses of treatment with weekly doses of engineered T cells targeting B7H3-expressing tumor cells. The goal is safe administration and interaction of these CAR T cells with the tumor.See study design

What are the potential side effects?

Potential side effects include reactions related to immune response such as inflammation around the site where the CAR T cells are administered or throughout the body, symptoms due to cytokine release syndrome (fever, fatigue), neurological events (headaches, confusion), and potential risks associated with inserting a catheter into the brain.

Eligibility Criteria

Inclusion Criteria

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

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I am between 1 and 26 years old.

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My brain cancer has returned or is not responding to treatment, or I have DIPG/DMG after finishing standard therapy.

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I can undergo apheresis or have apheresis material ready for use.

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I can care for myself but may need occasional help.

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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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 7 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 7 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 7 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 B7H3-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 B7H3-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 B7H3-specific CAR T cells distribution within the cerebrospinal fluid (CSF) and peripheral blood

Assessment of disease response of B7H3-expressing DIPG and DMG tumors to B7H3 specific CAR T cell therapy delivered into the CNS

Assessment of disease response of B7H3-expressing refractory or recurrent central nervous system (CNS) tumors to B7H3 specific CAR T cell therapy delivered into the tumor cavity or into the CNS

Other outcome measures

Quantitative biomarker assessment of anti tumor CAR T cell functional activity

Trial Design

3Treatment groups

Experimental Treatment

Group I: ARM C (DIPG)Experimental Treatment1 Intervention

Patients with DIPG for whom CAR T cells will be delivered into the ventricular system

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

Patients with non-DIPG either infratentorial tumors or leptomeningeal tumors for which the CAR T cells will be delivered into the ventricular system

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

Patients with non-DIPG supratentorial tumors for which CAR T cells will be delivered into the tumor resection cavity

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Seattle Children's HospitalLead Sponsor

302 Previous Clinical Trials

5,216,917 Total Patients Enrolled

2 Trials studying Diffuse Intrinsic Pontine Glioma

125 Patients Enrolled for Diffuse Intrinsic Pontine Glioma

Nick Vitanza, MDStudy ChairSeattle Children's Hospital

1 Previous Clinical Trials

72 Total Patients Enrolled

1 Trials studying Diffuse Intrinsic Pontine Glioma

72 Patients Enrolled for Diffuse Intrinsic Pontine Glioma

Media Library

SCRI-CARB7H3(s) (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04185038 — Phase 1

Diffuse Intrinsic Pontine Glioma Research Study Groups: ARM A (Tumor Cavity Infusion), ARM C (DIPG), ARM B (Ventricular System Infusion)

Diffuse Intrinsic Pontine Glioma Clinical Trial 2023: SCRI-CARB7H3(s) Highlights & Side Effects. Trial Name: NCT04185038 — Phase 1

SCRI-CARB7H3(s) (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04185038 — Phase 1

Frequently Asked Questions

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

How reliable is SCRI-CARB7H3(s); B7H3-specific chimeric antigen receptor (CAR) T cell therapy for humans?

"As this is only a Phase 1 clinical trial, the safety of SCRI-CARB7H3(s); B7H3-specific chimeric antigen receptor (CAR) T cell has been estimated to be relatively low with a score of 1."

Answered by AI

Who is eligible to join this medical research program?

"This clinical trial is recruiting 90 children, ranging between one year old to 26 years of age that have glioma. Further criteria for enrolment include: Having reached the age of consent (1 Year), Being a minimum 30 days removed from their most recent cellular infusion, Possessing refractory or recurrent CNS disease with no standard treatments available, Diagnosis of DIPG or DMG post completion of regular therapies, Tolerance to apheresis and having an apheresis product ready for manufacturing use, 3 half lives or 30 days since last dose of anti-tumor antibody treatment (whichever is shorter), Life expectancy greater"

Answered by AI

Is the enrollment for this research restricted to adults?

"Patient eligibilty for this trial is limited to those aged 1 year and above, but not exceeding 26 years of age."

Answered by AI

How many participants are currently involved in this research project?

"Affirmative. The clinical trial, which was initially announced on December 11th 2019, is currently recruiting patients according to the information available online at clinicaltrials.gov. 90 participants are needed for this study, and recruitment will take place in a single location."

Answered by AI

Are there any opportunities for prospective participants to join this medical research?

"Affirmative. The clinicaltrials.gov database reflects that this trial, which was initially launched on December 11th 2019, is still recruiting participants. Approximately 90 volunteers must be enrolled from a single centre."

Answered by AI

Recent research and studies

Frontiers in Bioscience-LandmarkJournal

CAR-T Cells Targeting Immune Checkpoint Pathway Players

Golubovskaya, Vita. 2022. “CAR-T Cells Targeting Immune Checkpoint Pathway Players”. Frontiers in Bioscience-landmark. IMR Press. doi:10.31083/j.fbl2704121.

clinicaltrials.govStudy

Study of B7-H3-Specific CAR T Cell Locoregional Immunotherapy for Diffuse Intrinsic Pontine Glioma/Diffuse Midline Glioma and Recurrent or Refractory Pediatric Central Nervous System Tumors

Colleen Annesley 2019. "Study of B7-H3-Specific CAR T Cell Locoregional Immunotherapy for Diffuse Intrinsic Pontine Glioma/Diffuse Midline Glioma and Recurrent or Refractory Pediatric Central Nervous System Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04185038.

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