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CAR T-cell Therapy
CD-19 CAR T for Stiff Person Syndrome
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
* Rigidity of limb and axial (trunk) muscles prominent in the abdominal and thoracolumbar paraspinal areas and making bending difficult
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new therapy using modified immune cells to treat patients with Stiff Person Syndrome that has not responded to other treatments.
Who is the study for?
This trial is for people with Stiff Person Syndrome who haven't improved after at least one immunomodulatory therapy. They should experience spasms triggered by noise, touch, or stress and have high levels of specific antibodies in their blood or CSF. Participants need to be able to walk and not have any other neurological diseases causing stiffness.
What is being tested?
The study tests a new treatment using Anti-CD19 Chimeric Antigen Receptor T Cell (CAR T) Therapy following a standard lymphodepletion regimen. It's designed for those whose Stiff Person Syndrome hasn't responded to usual treatments.
What are the potential side effects?
Potential side effects may include immune system reactions, infusion-related responses, fatigue, fever, headaches, and possible complications from the lymphodepletion process prior to CAR T-cell infusion.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have stiffness in my limbs and trunk that makes bending hard.
Select...
I do not have any other brain conditions causing my stiffness.
Select...
I still have symptoms after trying at least one immune therapy.
Select...
I can walk and move around on my own.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
To evaluate the safety of KYV-101
Secondary study objectives
To characterize the pharmacodynamics (PD)
To characterize the pharmacokinetics (PK)
To evaluate efficacy of KYV-101
+1 moreAwards & 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 Treatment1 Intervention
Dosing with KYV-101 CAR T cells
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Who is running the clinical trial?
Kyverna TherapeuticsLead Sponsor
10 Previous Clinical Trials
292 Total Patients Enrolled
MDStudy DirectorKyverna Therapeutics
1,003 Previous Clinical Trials
945,215 Total Patients Enrolled