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NCT03618381 · ClinicalTrials.gov registry record · Phase 1
EGFR806 CAR T Cell Immunotherapy for Recurrent/Refractory Solid Tumors in Children and Young Adults
A Phase 1 study of Osteosarcoma and Rhabdomyosarcoma, sponsored by Seattle Children's Hospital.
- Active
- Registry status
- Phase 1
- Development phase
- 44
- Enrollment target
- 1
- Study location
NCT03618381 is a Phase 1 study of Osteosarcoma and Rhabdomyosarcoma that is active but no longer recruiting, run by Seattle Children's Hospital. The registered enrollment target is 44 participants, below the 301-participant average among 46 other Osteosarcoma trials with a reported enrollment target (85% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03618381, a Phase 1 study of Osteosarcoma and Rhabdomyosarcoma, is active but no longer recruiting, sponsored by Seattle Children's Hospital.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 44 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a phase I, open-label, non-randomized study that will enroll pediatric and young adult research participants with relapsed or refractory non-CNS solid tumors to evaluate the safety, feasibility, and efficacy of administering T cell products derived from the research participant's blood that have been genetically modified to express a EGFR-specific receptor (chimeric antigen receptor, or CAR) that will target and kill solid tumors that express EGFR and the selection-suicide marker EGFRt. EGFRt is a protein incorporated into the cell with our EGFR receptor which is used to identify the modified T cells and can be used as a tag that allows for elimination of the modified T cells if needed. On Arm A of the study, research participants will receive EGFR-specific CAR T cells only. On Arm B of the study, research participants will receive CAR T cells directed at EGFR and CD19, a marker on the surface of B lymphocytes, following the hypothesis that CD19+ B cells serving in their normal role as antigen presenting cells to T cells will promote the expansion and persistence of the CAR T cells. The CD19 receptor harbors a different selection-suicide marker, HERtG. The primary objectives of the study will be to determine the feasibility of manufacturing the cell products, the safety of the T cell product infusion, to determine the maximum tolerated dose of the CAR T cells products, to describe the full toxicity profile of each product, and determine the persistence of the modified cell in the subject's body on each arm. Subjects will receive a single dose of T cells comprised of two different subtypes of T cells (CD4 and CD8 T cells) felt to benefit one another once administered to the research participants for improved potential therapeutic effect. The secondary objectives of this protocol are to study the number of modified cells in the patients and the duration they continue to be at detectable levels. The investigators will also quantitate anti-tumor efficacy on each
Conditions Studied
Interventions
- BIOLOGICAL second generation 4-1BBζ EGFR806-EGFRt
- BIOLOGICAL second generation 4-1BBζ EGFR806-EGFRt and a second generation 4 1BBζ CD19-Her2tG
Study Locations (1)
Washington
- Seattle Children's Hospital - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2019-06-18 |
| Est. Completion | 2040-06 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03618381
The ClinicalTrials.gov registry entry for NCT03618381 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 44 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 301-participant average among 46 other Osteosarcoma trials with a reported enrollment target (85% 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 Osteosarcoma appearing as the primary indexed condition, and to 2 interventions - of which second generation 4-1BBζ EGFR806-EGFRt is the first listed.
NCT03618381 reports 1 study location spanning 1 distinct geographic area - top geographies include Washington.
Frequently Asked Questions
What is clinical trial NCT03618381 about?
NCT03618381 is a clinical study titled "EGFR806 CAR T Cell Immunotherapy for Recurrent/Refractory Solid Tumors in Children and Young Adults". This is a phase I, open-label, non-randomized study that will enroll pediatric and young adult research participants with relapsed or refractory non-CNS solid tumors to evaluate the safety, feasibility, and efficacy of administering T cell products derived from the research participant's blood that ...
What is the current status of trial NCT03618381?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 44 participants. The study started on 2019-06-18. Estimated completion is 2040-06.
What conditions does trial NCT03618381 study?
This clinical trial studies the following conditions: Osteosarcoma, Rhabdomyosarcoma, Carcinoma, Ewing Sarcoma, Germ Cell Tumor.
What interventions are being tested in trial NCT03618381?
The interventions under investigation include: second generation 4-1BBζ EGFR806-EGFRt (BIOLOGICAL), second generation 4-1BBζ EGFR806-EGFRt and a second generation 4 1BBζ CD19-Her2tG (BIOLOGICAL).
Who is sponsoring clinical trial NCT03618381?
This trial is sponsored by Seattle Children's Hospital, which has 168 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03618381 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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