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

NCT06298019 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2025-05-21

No results posted yet for this 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;

Conditions

  • Dermatomyositis

Interventions

BIOLOGICAL

KYV-101

The investigational product, KYV-101, is an autologous CD19-targeted CAR T-cell immunotherapy.

Sponsors & Collaborators

Principal Investigators

  • David Fiorentino, MD, PhD · Stanford University

  • Lorinda Chung, MD · Stanford University

  • Everett Meyer, MD · Stanford University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
25 Years
Max Age
72 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-02
Primary Completion
2027-04-30
Completion
2039-04-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06298019 on ClinicalTrials.gov