Actively Recruiting
Study of KYV-101 Anti-CD19 CAR T Therapy in Adult Dermatomyositis
Led by Stanford University · Updated on 2025-05-21
21
Participants Needed
2
Research Sites
765 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Study of KYV-101 Anti-CD19 CAR T Therapy in Adult Dermatomyositis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of probable or definite idiopathic inflammatory myopathy with dermatomyositis according to 2017 EULAR/ACR criteria
- Age over 25 and under 72 years at consent
- Refractory disease with previous failure or intolerance to glucocorticoids and at least two non-glucocorticoid immunosuppressive therapies for at least 12 weeks within 24 months prior to screening
- Moderate-to-severe dermatomyositis indicated by muscle weakness (MMT-8 score under 142/150) or skin disease (CDASI-a score 19 or higher)
- At least two other abnormal IMACS Core Set Measures including patient or physician global assessments, extramuscular activity, elevated muscle enzymes, or HAQ-DI score 0.25 or higher
- For those enrolling based on muscle weakness, active muscle disease confirmed by enzyme levels, MRI, or EMG within last 3 months
- ECOG performance status of 0 or 1
- Adequate organ function including specified blood counts, liver enzymes, bilirubin, kidney function, and oxygen saturation
- Up to date on recommended vaccinations including COVID-19
- Negative pregnancy test for women of childbearing potential
- Agreement to use highly effective contraception during study and for 1 year after infusion
- Agreement not to donate eggs or sperm for 1 year after infusion
You will not qualify if you...
- Severe muscle damage including Myositis Global Damage Index of 5 or more, severe muscle atrophy, wheelchair-bound at home, or MMT-8 score 80 or less
- MDA5-positive rapidly progressing interstitial lung disease; stable ILD without oxygen requirement allowed
- Other muscular inflammation or myopathy diagnoses besides dermatomyositis except Sjogren's syndrome overlap
- Severe musculoskeletal or neuromuscular conditions preventing assessment
- Interstitial lung disease requiring oxygen therapy or with low lung function; pulmonary hypertension requiring treatment
- Current gangrene of a digit
- Prior cellular immunotherapy or gene therapy
- History of stem cell transplant
- Other systemic autoimmune diseases requiring immunosuppressive therapy
- Plans to receive live attenuated vaccines after consent
- Positive hepatitis B surface antigen or active hepatitis C infection
- Positive HIV test
- Positive SARS-CoV-2 test
- Primary immunodeficiency
- History of splenectomy
- Significant neurological disorders increasing risk
- Impaired cardiac function or significant cardiac disease as specified
- Previous or ongoing malignancy except certain treated cancers in remission
- Serious uncontrolled medical conditions or infections
- Recent thromboembolic events
- Ongoing toxicity from previous therapy not resolved
- Major surgery within 4 weeks before or planned within 4 weeks after infusion
- Allergies or intolerances to KYV-101 components or related drugs
- Pregnancy, breastfeeding, or plans to conceive within 1 year after infusion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Stanford University
Palo Alto, California, United States, 94304-5755
Actively Recruiting
2
Stanford University
Stanford, California, United States, 94305
Actively Recruiting
Research Team
L
Lori Panu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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