Actively Recruiting
A Study of Anti-CD19 Chimeric Antigen Receptor T-Cell ( CAR-T) Therapy in Subjects With Non-relapsing and Progressive Forms of Multiple Sclerosis
Led by Stanford University · Updated on 2026-02-27
12
Participants Needed
1
Research Sites
163 weeks
Total Duration
On this page
Sponsors
S
Stanford University
Lead Sponsor
K
Kyverna Therapeutics
Collaborating Sponsor
AI-Summary
What this Trial Is About
A Study of Anti-CD19 Chimeric Antigen Receptor T Cell Therapy in Subjects with Non-relapsing and Progressive Forms of Multiple Sclerosis
CONDITIONS
Official Title
A Study of Anti-CD19 Chimeric Antigen Receptor T-Cell ( CAR-T) Therapy in Subjects With Non-relapsing and Progressive Forms of Multiple Sclerosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 65 years at screening
- Diagnosis of Multiple Sclerosis by 2017 McDonald Criteria
- Progressive Multiple Sclerosis by 2014 Lublin MS criteria
- Presence of varicella-zoster virus antibodies or completed at least one dose of Shingrix vaccine at least 4 weeks before treatment
- Presence of anti Epstein-Barr virus antibodies
- Adequate organ and marrow function with specific blood counts and organ function limits as defined
- Negative tests for HIV, hepatitis B, hepatitis C, syphilis, HTLV, herpes simplex virus, varicella-zoster, and cytomegalovirus within 40 days of apheresis
- Negative pregnancy test for females of childbearing potential
- Willingness to use effective birth control during the study and for 12 months after CAR T infusion
- Ability to understand and sign informed consent
- Vital signs within acceptable ranges and stable blood pressure if on medication
You will not qualify if you...
- History of neuromyelitis optica spectrum disorder or MOG antibody associated disease
- Prior investigational agent treatment within 3 months or 5 half-lives
- Starting new disease modifying therapy between apheresis and lymphodepletion (except methylprednisolone bridging)
- History of CNS or spinal cord tumor, metabolic or infectious myelopathy, inherited progressive CNS disorder, sarcoidosis, or other non-MS progressive neurologic condition affecting study assessments
- History of myelodysplastic syndrome or sickle cell anemia
- Coagulation abnormalities or positive antiphospholipid antibodies
- Active uncontrolled infections requiring hospitalization or IV antimicrobials within 4 weeks
- Psychiatric or psychosocial issues posing unacceptable risk
- History of liver cirrhosis
- History of malignancy except certain skin or in situ cancers unless disease free for 3 years
- Active HIV, hepatitis B, or hepatitis C infection
- CNS disorders impairing neurotoxicity evaluation
- Recent significant cardiac events or unstable cardiac disease
- Use of anticoagulation or antiplatelet therapy
- History of autoimmune diseases requiring immunosuppression within 2 years
- Primary immune deficiency disease
- Unlikely to complete study visits or comply with requirements
- Severe hypersensitivity to study agents or excipients
- Any condition interfering with safety or efficacy assessment
- Prior total lymphoid irradiation or high-dose mitoxantrone
- Prior autologous hematopoietic stem cell transplantation or cellular immunotherapy
- Prior anti-CD20 monoclonal antibody therapy within 9 months
- Prior solid organ transplantation
- Significant cardiac dysfunction or disease as detailed
- Prior splenectomy
- Moderate or worse asthma or COPD
- Prolonged corrected QT interval
- Valvular heart disease
- Moderate or worse renal impairment
- Prior Mavenclad treatment without 9-month washout
- History of seizure disorder
- Prior cellular immunotherapy or gene therapy treatment directed at any target
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Stanford Multiple Sclerosis Center
Palo Alto, California, United States, 94304
Actively Recruiting
Research Team
M
Multiple Sclerosis and Neuroimmunology Study Team
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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