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CAR T-cell Therapy

CAR T-Cell Therapy for Myasthenia Gravis

Phase 2
Recruiting
Research Sponsored by Kyverna Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Myasthenia Gravis Foundation of America (MGFA) Class IIB-IV
Diagnosis of MG with presence of autoantibodies to AChR and MuSK
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new therapy for people with Myasthenia Gravis using a type of immune cells called Chimeric Antigen Receptor T cells that target a specific protein on immune cells

Who is the study for?
This trial is for individuals with Myasthenia Gravis, specifically those who have autoantibodies to AChR and MuSK. Participants should be experiencing moderate to severe muscle weakness (MGFA Class IIB-IV).
What is being tested?
The study is testing KYV-101, a type of CAR T-cell therapy designed to target CD19 on immune cells, alongside a standard treatment that reduces the number of immune cells (lymphodepletion regimen).
What are the potential side effects?
Potential side effects may include reactions related to the immune system's response such as fever, fatigue, headache, or more serious conditions like changes in blood pressure or abnormal blood cell counts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My myasthenia gravis is moderate to severe.
Select...
I have been diagnosed with MG and have antibodies to AChR and MuSK.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
To assess PRO (Patient Outcome Rate) after infusion of KYV-101
To assess PRO (Patient Reported Outcome) after infusion of KYV-101

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?

Kyverna TherapeuticsLead Sponsor
10 Previous Clinical Trials
297 Total Patients Enrolled
MDStudy DirectorKyverna Therapeutics, Inc.
998 Previous Clinical Trials
944,591 Total Patients Enrolled
1 Trials studying Myasthenia Gravis
238 Patients Enrolled for Myasthenia Gravis
~13 spots leftby May 2026
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