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KYV-101 for Adult Dermatomyositis

This study is looking at a cell therapy called KYV-101 for adults with dermatomyositis, an autoimmune disease. KYV-101 uses your own white blood cells, called T-cells, which are specially modified to target and remove other cells that have a protein called CD19 on their surface. The main goal of this study is to see how safe KYV-101 is by tracking any side effects you might experience over 24 weeks. You may be able to join if you are between 25 and 72 years old, have been diagnosed with dermatomyositis, and your condition hasn't improved with standard treatments like glucocorticoids and at least two other therapies. This study plans to enroll 21 participants.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 21 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be monitored for adverse events for 24 weeks after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06298019

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

Recruiting
PHASE1Ages 25–72InterventionalTreatment
Stanford University
~21 participants
Updated 2025-05-21 on ClinicalTrials.gov
What's tested:KYV-101

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants experiencing adverse events
Measured over 24 weeks

Conditions

Dermatomyositis

Explore related trials

Dermatomyositis

Where it's being run

2 sites across 1 states
California2

Study leadership

  • David Fiorentino, MD, PhD · PRINCIPAL_INVESTIGATOR · Stanford University
  • Lorinda Chung, MD · PRINCIPAL_INVESTIGATOR · Stanford University
  • Everett Meyer, MD · PRINCIPAL_INVESTIGATOR · Stanford University

Who to contact

Lori Panu
[email protected]
650-724-1703
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Patient global VAS≥2 cm.
Physician's global VAS ≥2 cm.
Global extramuscular activity score ≥2 cm.
Elevation of at least one of the muscle enzymes (CK, AST, ALT, aldolase, LDH) \>1.5 times upper limit of normal.
HAQ-DI≥0.25.
Creatine kinase, aldolase, LDH, AST, or ALT (if deemed due to muscle inflammation by investigator) ≥2×ULN.
MRI evidence of active myositis within last 3 months.
EMG evidence of active myositis within last 3 months.
Established use of hormonal methods of contraception associated with inhibition of ovulation (eg, oral, inserted, injected, implanted, transdermal), provided the subject or male subject's female partner plans to remain on the same treatment throughout the entire study and has been using that hormonal contraceptive for an adequate period of time to ensure effectiveness.
Correctly placed copper containing- intrauterine device or intrauterine hormone-replacing system.
Male sterilization with absence of sperm in the post-vasectomy ejaculate.
Female sterilization (bilateral tubal ligation/bilateral salpingectomy or bilateral tubal occlusive procedure (provided that occlusion has been confirmed).
Sexual abstinence, defined as completely and persistently refraining from all heterosexual intercourse (including during the entire period of risk associated with the study treatments) may obviate the need for contraception ONLY if this is the preferred and usual lifestyle of the subject. 7. Male subjects, if not surgically sterilized, must agree to use highly effective method of contraception and not donate sperm from the time of signing the ICF until 1 year after the KYV-101 infusion. 8. For females: a negative pregnancy test at screening and prior to lymphodepletion chemotherapy. 9. Women and men must agree not to donate eggs (ova, oocytes) or sperm, respectively, until at least 1 year after receiving a KYV-101 infusion.

Exclusion

Severe muscle damage as per one of the following criteria:
MDA5-positive rapidly progressing interstitial lung disease (subjects with stable ILD not requiring supplemental oxygen are eligible).
Findings of muscular inflammation or myopathy other than the indication, such as polymyositis (PM), immune mediated necrotizing myopathy (IMNM), inclusion body myositis (IBM), cancer-associated myositis (myositis diagnosed within 2 years of cancer), drug-induced myopathy, amyloid myopathy, muscular dystrophy, metabolic myopathies, or myositis in the context of significant overlap with another systemic autoimmune rheumatologic disease (overlap myositis), except with Sjogren's syndrome.
Generalized, severe musculoskeletal or neuro-muscular conditions other than DM that prevent a sufficient assessment of the patient by the investigator. 2. Subject with any of the following:
Patients with ILD associated with any of the following oRequiring O2 therapy and/or FVC ≤45% of predicted or DLCO ≤40% of predicted at screening oEvidence of PH as defined as estimated RVSP or ≥45 mmHg or right atrial or ventricular enlargement or dilatation, unless subsequent RHC shows no PH.

What this trial measures

  • Number of participants experiencing adverse events24 weeks

    This outcome is to characterize the safety and tolerability of administering KYV-101 CAR T cells that meet the established criteria to patients with DM. Participants experiencing adverse events including laboratory abnormalities will be reported.