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Study of KYV-101 Anti-CD19 CAR T Therapy in Adult Dermatomyositis

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clinicaltrials.gov/study/NCT06298019
Is a
‌
Clinical study
0

Clinical Study attributes

NCT Number
NCT062980190
Health Conditions in Trial
Dermatomyositis
Dermatomyositis
0
Trial Recruitment Size
210
Trial Sponsor
Stanford University
Stanford University
0
Clinical Trial Start Date
2024
0
Primary Completion Date
2027
0
Study Completion Date
2039
0
Clinical Trial Study Type
Interventional0
Interventional Trial Purpose
Treatment0
Intervention Type
Biological0
Interventional Trial Phase
Phase 10
Participating Facility
Stanford University
Stanford University
0
Official Name
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 Dermatomyositis0
Last Updated
March 7, 2024
0
Allocation Type
NA0
Intervention Model
Sequential Assignment0
Masking Type
None (Open Label)0

Other attributes

Intervention Treatment
KYV-1010
Study 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 patient's B cells. B cells are an important part of a person's 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 patient's own tissues) and causing disease. The idea is that the therapy will "wipe out" all/most 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;

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