Ignite Creation Date:
2024-05-06 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 12:51 PM
Study NCT ID:
NCT03618381
Status:
RECRUITING
Last Update Posted:
2024-04-09
First Post:
2018-07-16
Brief Title:
EGFR806 CAR T Cell Immunotherapy for RecurrentRefractory Solid Tumors in Children and Young Adults
Sponsor:
Seattle Childrens Hospital
Organization:
Seattle Childrens Hospital
Study Overview
Official Title:
Phase I Study of EGFR806 CAR T Cell Immunotherapy for RecurrentRefractory Solid Tumors in Children and Young Adults
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 participants 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 subjects 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 arm Subjects who experience significant and potentially life-threatening toxicities other than clinically manageable toxicities related to T cells working called cytokine release syndrome will receive infusions of cetuximab an antibody commercially available that targets EGFRt or trastuzumab an antibody commercially available that targets HER2tG to assess the ability of the EGFRt on the T cells to be an effective suicide mechanism for the elimination of the transferred T cell products
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None