Ignite Creation Date:
2024-05-06 @ 8:12 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06298019
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-07
First Post:
2023-12-16
Brief Title:
Study of KYV-101 Anti-CD19 CAR T Therapy in Adult Dermatomyositis
Sponsor:
Stanford University
Organization:
Stanford University
Study Overview
Official Title:
Phase 1B Open-Label Study of KYV-101 an Autologous Fully-Human Anti-CD19 Chimeric Antigen Receptor T-Cell CD19 CAR T Therapy in Adult Patients With Treatment Refractory Dermatomyositis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
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:
The goal of this clinical trial is to characterize to understand the effects of a type of cell therapy called Chimeric Antigen Receptor T lymphocyte CAR T therapy in adult patients with the autoimmune disease dermatomyositis This study will utilize a technology that modifies a type of white blood cell called the cytotoxic T lymphocyte-this T cell normally functions in the immune system to kill infected or potentially harmful cells in the body In CAR T therapy the patients white blood cells are harvested and the cytotoxic T cells are isolated and modified such that they are programmed to kill any cell that has a protein structure called CD19 on its outer surface membrane Since the CD19 protein is only present on a type of white blood cell called the B lymphocyte when these re-engineered cytotoxic T lymphocytes are then given back to the patient by an infusion these cells will seek out and kill essentially all of the patients B cells B cells are an important part of a persons immune system and have many functions including the production of antibodies It is thought that in dermatomyositis and other autoimmune diseases a tiny subset of these B cells plays a large role in making autoantibodies antibodies directed against the patients own tissues and causing disease The idea is that the therapy will wipe out allmost of the B cells in the patient so that they can make an entirely new set of B cells to recreate a functional immune system without the autoimmune disease
The main questions the study intends to answer are
Understanding how well patients tolerate undergoing this therapy in terms of side effects
Getting an early idea if this therapy can help certain aspects of the autoimmune disease including inflammation in the skin muscles and lungs
The main questions the study intends to answer are
Understanding how well patients tolerate undergoing this therapy in terms of side effects
Getting an early idea if this therapy can help certain aspects of the autoimmune disease including inflammation in the skin muscles and lungs
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