Ignite Creation Date:
2024-05-06 @ 2:59 PM
Last Modification Date:
2024-10-26 @ 1:40 PM
Study NCT ID:
NCT04483778
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-23
First Post:
2020-07-14
Brief Title:
B7H3 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 B7H3 CAR T Cell Immunotherapy for RecurrentRefractory Solid Tumors in Children and Young Adults
Status:
ACTIVE_NOT_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 B7H3-specific receptor chimeric antigen receptor or CAR that will target and kill solid tumors that express B7H3 On Arm A of the study research participants will receive B7H3-specific CAR T cells only On Arm B of the study research participants will receive CAR T cells directed at B7H3 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 Arm A CAR T cells include the protein EGFRt and Arm B CAR T cells include the protein HER2tG These proteins can be used to both track and destroy the CAR T cells in case of undue toxicity 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 participants body on each arm Participants 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 Participants 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