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A Study of KYV-101 CAR-T Cell Therapy for Progressive Multiple Sclerosis

This study is testing a new treatment called KYV-101 anti-CD19 CAR-T cell therapy for people with progressive forms of Multiple Sclerosis (MS). This includes both primary progressive MS (PPMS) and secondary progressive MS (SPMS) that is not relapsing. The treatment involves using your own immune cells, called T-cells, which are specially modified to target specific cells (CD19 cells) that are believed to play a role in MS. Before receiving KYV-101, you will also receive a standard lymphodepletion regimen, which is a type of chemotherapy to prepare your body for the CAR-T cells. Researchers will be looking at the frequency of dose-limiting toxicities (side effects that are severe enough to stop or reduce treatment) over 12 months to see how safe the treatment is. The study is looking for 12 participants between 18 and 65 years old who have a confirmed diagnosis of progressive MS and have antibodies for varicella-zoster virus (chickenpox/shingles) or have received the Shingrix vaccine.

Study design
This is an interventional study with a planned enrollment of 12 participants. The phase of the study is not specified.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint measures toxicities for up to 12 months 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.

NCT06138132

A Study of Anti-CD19 Chimeric Antigen Receptor T-Cell ( CAR-T) Therapy in Subjects With Non-relapsing and Progressive Forms of Multiple Sclerosis

Recruiting
PHASE1Ages 18–65InterventionalTreatment
Stanford University
~12 participants
Updated 2026-02-27 on ClinicalTrials.gov
What's tested:KYV-101 anti-CD19 CAR-T cell therapyStandard lymphodepletion regimen

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Frequency of dose limiting toxicities at each dose level
Measured over Up to 12 months

Conditions

Multiple Sclerosis
Multiple Sclerosis, Primary Progressive
Multiple Sclerosis, Secondary Progressive

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Multiple SclerosisCD19 GeneVZVX-linked Lymphoproliferative Syndrome 1

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Jeffrey Dunn, MD · PRINCIPAL_INVESTIGATOR · Stanford University

Who to contact

Multiple Sclerosis and Neuroimmunology Study Team
[email protected]
650-387-5907
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Absolute neutrophil count (ANC) ≥ 2000/uL.
Platelet count ≥ 150,000/uL.
Absolute lymphocyte count ≥ 1000/uL.
Serum immunoglobulin G (IgG) ≥ 500mg/dL.
Hemoglobin ≥ 9 g/dL.
Adequate renal, hepatic, pulmonary and cardiac function defined as:
Creatinine ≤ 2mg/dL or creatinine clearance (as estimated by Cockcroft Gault Equation) ≥ 60 mL/min.
Serum alanine transaminase (ALT)/aspartate aminotransferase (AST) ≤ 3 upper limit of normal (ULN).
Total bilirubin ≤ 1.5 mg/dl, except in subjects with Gilbert's syndrome
Cardiac ejection fraction ≥ 40%, no evidence of physiologically significant pericardial effusion as determined by an ECHO, and no clinically significant ECG findings.
Baseline oxygen saturation \> 94% on room air. 7. Testing for
Hepatitis B core antibody (HBc Ab)
Hepatitis C antibody (HCV Ab)
Hepatitis B surface antigen (Hep B surf. AG)
HIV 1\&2 Ab
Syphilis Screen
Human T-cell lymphotropic virus (HTLV) Ab I \& II
Nucleic acid test multiplex (NAT MPX) for HIV, HCV, HBV
Herpes Simplex Virus 1 \& 2 IgG panel
Varicella-Zoster (VZ) IgG
Cytomegalovirus (CMV) Total Ab
Systolic Blood Pressure (mmHg) ≥ 100 and ≤ 150
Diastolic Blood pressure (mmHg) ≥ 60 and ≤ 90
To ensure subject safety and stability, any subject who is noted to have a BP \> 150/90 mm Hg should be stable on anti-hypertensive medications with repeated BP ≤150/90 for at least one month prior to enrollment in the study
Heart Rate ≥ 60 and ≤ 100 bpm
Oral Temperature ≤ 37.7 C/afebrile
Respiratory rate ≥ 12 and ≤ 20bpm
a. Unstable angina or myocardial infarction or coronary artery bypass graft (CABG) within 6 months prior to apheresis.
b. New York Heart Association (NYHA) stage III or IV congestive heart failure.
c. History of clinically significant cardiac arrhythmia (eg, ventricular tachycardia), complete left bundle branch block, high-grade atrioventricular (AV) block.
d. History of severe nonischemic cardiomyopathy.
e. Left ventricular ejection fraction (LVEF) \<45% as assessed by echocardiogram (ECHO) or multi-gated acquisition (MUGA) scan (performed ≤8 weeks of apheresis).
f. Active, current cardiac manifestations of systemic lupus erythematosus (SLE) including pericarditis, pericardial effusion, and myocarditis. 26. Prior history of splenectomy 27. History of moderate or worse than moderate asthma or chronic obstructive pulmonary disease (COPD) 28. Corrected QT interval (QTc) \>450msec in males or \>470msecs in females 29. Subjects with valvular heart disease (regurgitation, stenosis or atresia 30. Moderate or worse renal impairment using criteria
Stage 1: Kidney damage with normal or increased GFR (\>90 mL/min/1.73 m\^2).
Stage 2: Mild reduction in GFR (60-89 mL/min/1.73 m\^2).
Stage 3a: Moderate reduction in GFR (45-59 mL/min/1.73 m\^2).
Stage 3b: Moderate reduction in GFR (30-44 mL/min/1.73 m\^2).
Stage 4: Severe reduction in GFR (15-29 mL/min/1.73 m\^2).
Stage 5: Kidney failure (GFR \< 15 mL/min/1.73 m\^2 or dialysis) 31. Previously received Mavenclad, yet drug washout is ≤9 months. 32. History of a seizure disorder even if the seizure disorder is well controlled with anti-epileptics 33. Prior history of treatment with cellular immunotherapy (e.g. CAR T) gene therapy product directed as any target.

What this trial measures

  • Frequency of dose limiting toxicities at each dose levelUp to 12 months