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CAR T-cell Therapy

CAR T-Cell Therapy for Multiple Sclerosis

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
Key
Subject must have a history of diagnosis of primary progressive or secondary progressive MS.
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 called CD19 CAR T in patients with progressive multiple sclerosis that has not responded to other treatments.

Who is the study for?
This trial is for people with a tough form of multiple sclerosis (MS) that hasn't improved after other treatments. Participants must have been diagnosed with primary or secondary progressive MS and shown worsening disability despite previous anti-CD20 mAB therapy.
What is being tested?
The study tests a new therapy using modified T-cells, called Anti-CD19 CAR T-cell therapy (KYV-101), to see if it can help manage severe MS. It's given after a standard treatment that reduces the number of immune cells in the body.
What are the potential side effects?
CAR T-cell therapies like KYV-101 can cause flu-like symptoms, changes in blood pressure, difficulty breathing, confusion or seizures. There might also be reactions at the infusion site such as pain or swelling.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with progressive MS.

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 characterize the Pharmacodynamics (PD)
To characterize the pharmacokinetics (PK)
To characterize the safety and tolerability of KYV-101
+2 more

Awards & Highlights

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

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: KYV-101 CAR-T cells with lymphodepletion conditioningExperimental Treatment2 Interventions
Dosing with KYV-101 CAR T cells
Group II: Anti- CD20 mAbActive Control1 Intervention
Dosing with anti-CD20 mAb

Find a Location

Who is running the clinical trial?

Kyverna TherapeuticsLead Sponsor
10 Previous Clinical Trials
197 Total Patients Enrolled
2 Trials studying Multiple Sclerosis
22 Patients Enrolled for Multiple Sclerosis
MDStudy DirectorKyverna Therapeutics, Inc.
972 Previous Clinical Trials
939,888 Total Patients Enrolled
~80 spots leftby Apr 2027
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