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CAR T-cell Therapy

CAR T-cell Therapy for Multiple Sclerosis

Phase 1
Recruiting
Led By Jeffrey Dunn, MD
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient is ≥ 18 years old, and ≤55 years of age, at time of screening visit
Progressive MS by 2014 Lublin MS phenotypic criteria
Must not have
History of neuromyelitis optica spectrum disorder (NMOSD) or MOG antibody associated disease (MOGAD)
Impaired cardiac function or clinically significant cardiac disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
No Placebo-Only Group

Summary

This trial will use gene therapy to treat MS, testing if a modified immune cell can stop or slow the progression of the disease.

Who is the study for?
This trial is for adults aged 18-55 with progressive forms of Multiple Sclerosis, as per the McDonald and Lublin criteria. Participants must have certain antibody levels, normal organ function, no recent investigational drugs or specific treatments, and agree to contraception if applicable.
What is being tested?
The study tests KYV-101 anti-CD19 CAR-T cell therapy following a standard lymphodepletion regimen in patients with non-relapsing and progressive MS. It aims to evaluate the safety and effectiveness of this innovative treatment approach.
What are the potential side effects?
Potential side effects may include immune system reactions, infusion-related responses, changes in blood counts leading to increased infection risk or bleeding problems, fatigue, and possible impacts on liver or kidney function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 55 years old.
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My MS is getting worse according to the 2014 Lublin criteria.
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I have antibodies against the Epstein-Barr virus.
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My blood tests show normal immune and marrow function.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a history of NMOSD or MOGAD.
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I have heart problems that affect my daily activities.
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I have had my spleen removed.
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I have a history of moderate or severe asthma or COPD.
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I have a heart valve condition.
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My kidneys do not work well.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Incidence of adverse events (AEs) including clinical tolerance and laboratory abnormalities
To characterize the pharmacodynamics (PD)
To characterize the pharmacokinetics (PK)
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: KYV-101 CAR-T cells with lymphodepletion conditioningExperimental Treatment2 Interventions
Dosing with KYV-101 CAR T cells

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,475 Previous Clinical Trials
17,501,471 Total Patients Enrolled
3 Trials studying Multiple Sclerosis
197 Patients Enrolled for Multiple Sclerosis
Kyverna TherapeuticsIndustry Sponsor
10 Previous Clinical Trials
305 Total Patients Enrolled
2 Trials studying Multiple Sclerosis
130 Patients Enrolled for Multiple Sclerosis
Jeffrey Dunn, MDPrincipal InvestigatorStanford University
~8 spots leftby Jun 2027
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