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NCT04185038 · ClinicalTrials.gov registry record · Phase 1
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
A Phase 1 study of Diffuse Intrinsic Pontine Glioma and Ependymoma, sponsored by Seattle Children's Hospital.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 90
- Enrollment target
- 1
- Study location
NCT04185038 is a Phase 1 study of Diffuse Intrinsic Pontine Glioma and Ependymoma that is actively recruiting participants, run by Seattle Children's Hospital. The registered enrollment target is 90 participants, below the 132-participant average among 28 other Diffuse Intrinsic Pontine Glioma trials with a reported enrollment target (32% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04185038, a Phase 1 study of Diffuse Intrinsic Pontine Glioma and Ependymoma, is actively recruiting participants, sponsored by Seattle Children's Hospital.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 90 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a Phase 1 study of central nervous system (CNS) locoregional adoptive therapy with autologous CD4+ and CD8+ T cells lentivirally transduced to express a B7H3-specific chimeric antigen receptor (CAR) and EGFRt. CAR T cells are delivered via an indwelling catheter into the tumor resection cavity or ventricular system in children and young adults with diffuse intrinsic pontine glioma (DIPG), diffuse midline glioma (DMG), and recurrent or refractory CNS tumors. A child or young adult meeting all eligibility criteria, including having a CNS catheter placed into the tumor resection cavity or into their ventricular system, and meeting none of the exclusion criteria, will have their T cells collected. The T cells will then be bioengineered into a second-generation CAR T cell that targets B7H3-expressing tumor cells. Patients will be assigned to one of 3 treatment arms based on location or type of their tumor. Patients with supratentorial tumors will be assigned to Arm A, and will receive their treatment into the tumor cavity. Patients with either infratentorial or metastatic/leptomeningeal tumors will be assigned to Arm B, and will have their treatment delivered into the ventricular system. The first 3 patients enrolled onto the study must be at least 15 years of age and assigned to Arm A or Arm B. Patients with DIPG will be assigned to Arm C and have their treatment delivered into the ventricular system. The patient's newly engineered T cells will be administered via the indwelling catheter for two courses. In the first course patients in Arms A and B will receive a weekly dose of CAR T cells for three weeks, followed by a week off, an examination period, and then another course of weekly doses for three weeks. Patients in Arm C will receive a dose of CAR T cells every other week for 3 weeks, followed by a week off, an examination period, and then dosing every other week for 3 weeks. Following the two courses, patients in all Arms will undergo a series of studies
Conditions Studied
Interventions
- BIOLOGICAL SCRI-CARB7H3(s); B7H3-specific chimeric antigen receptor (CAR) T cel
Study Locations (1)
Washington
- Seattle Children's Hospital - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2019-12-11 |
| Est. Completion | 2041-05 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04185038
The ClinicalTrials.gov registry entry for NCT04185038 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 90 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 132-participant average among 28 other Diffuse Intrinsic Pontine Glioma trials with a reported enrollment target (32% lower). The listed sponsor is Seattle Children's Hospital, which has 168 total studies on file at ClinicalTrials.gov.
The record links to 10 conditions, with Diffuse Intrinsic Pontine Glioma appearing as the primary indexed condition, and to 1 intervention - of which SCRI-CARB7H3(s); B7H3-specific chimeric antigen receptor (CAR) T cel is the first listed.
NCT04185038 reports 1 study location spanning 1 distinct geographic area - top geographies include Washington.
Frequently Asked Questions
What is clinical trial NCT04185038 about?
NCT04185038 is a clinical study titled "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". This is a Phase 1 study of central nervous system (CNS) locoregional adoptive therapy with autologous CD4+ and CD8+ T cells lentivirally transduced to express a B7H3-specific chimeric antigen receptor (CAR) and EGFRt. CAR T cells are delivered via an indwelling catheter into the tumor resection cavi...
What is the current status of trial NCT04185038?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 90 participants. The study started on 2019-12-11. Estimated completion is 2041-05.
What conditions does trial NCT04185038 study?
This clinical trial studies the following conditions: Diffuse Intrinsic Pontine Glioma, Ependymoma, Germ Cell Tumor, Atypical Teratoid/Rhabdoid Tumor, Central Nervous System Tumor.
What interventions are being tested in trial NCT04185038?
The interventions under investigation include: SCRI-CARB7H3(s); B7H3-specific chimeric antigen receptor (CAR) T cel (BIOLOGICAL).
Who is sponsoring clinical trial NCT04185038?
This trial is sponsored by Seattle Children's Hospital, which has 168 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04185038 being conducted?
This trial has 1 study location across Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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