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

Part of paid clinical trials in Palo Alto, California.

Sponsor
Stanford University
Study ID
NCT06298019
Phase
PHASE1
Status
Recruiting
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Conditions

  • Dermatomyositis

Eligibility Criteria

Sex
ALL
Age
25 Years - 72 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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;

Key Dates

Start date
Aug 2, 2024
Status verified
Aug 2024
Primary completion
Apr 30, 2027
Completion
Apr 30, 2039

Study Design

Enrollment
21 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Active Intervention with CAR T
    All participants in the trial will receive an infusion of autologous, genetically modified CAR T cells specific for the CD19 antigen

Primary Outcome Measure

Number of participants experiencing adverse events [ Time Frame: 24 weeks ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Stanford UniversityPalo AltoCalifornia94304-5755
Swarna Nandyala
[email protected]
9258548296
Stanford UniversityStanfordCalifornia94305
Lori Panu
[email protected]
6507241703
Swarna Nandyala
[email protected]
Dr. David F Fiorentino (PRINCIPAL_INVESTIGATOR)

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