Status:
ACTIVE_NOT_RECRUITING
KYSA-8: A Study of Anti-CD19 Chimeric Antigen Receptor T-Cell (CD19 CAR T) Therapy, in Subjects With Treatment Refractory Stiff Person Syndrome
Lead Sponsor:
Kyverna Therapeutics
Conditions:
Stiff-Person Syndrome
SPS
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
A Study of Anti-CD19 Chimeric Antigen Receptor T-Cell Therapy for Subjects with Treatment Refractory Stiff Person Syndrome
Detailed Description
Stiff person syndrome (SPS) is a rare progressive immune-mediated disorder of the central nervous system (CNS) that is characterized by progressive rigidity and painful spasms of predominantly axial a...
Eligibility Criteria
Inclusion
- Key
- Subject must have been diagnosed SPS per the following criteria:
- Rigidity of limb and axial (trunk) muscles prominent in the abdominal and thoracolumbar paraspinal areas and making bending difficult
- Clinical or electrophysiological evidence of continuous contraction of agonist and antagonist muscles
- Episodic spasms precipitated by unexpected noises, tactile stimuli, or emotional upset
- Absence of any other neurologic disease that could explain the stiffness and rigidity
- High titer serum anti-GAD65 antibodies shown at screening -OR- seropositive for anti-glycine antibodies. If anti-GAD65 antibodies are lower than the high titer threshold peripherally but positive in the cerebrospinal fluid (CSF), the subject can be included. A prior documented high titer anti-GAD65 antibody level may be acceptable subject to sponsor review.
- Active symptoms with inadequate response to at least one immunomodulatory therapy.
- Stiffness index ≥2.
- At least 20 of the 25 enrolled subjects should be ambulatory.
- Key
Exclusion
- Bedridden subjects for more than 3 months.
- History of CNS or spinal cord tumor, metabolic or infectious cause of myelopathy, genetically inherited progressive CNS disorder, sarcoidosis, non-SPS progressive neurologic condition or progressive multifocal leukoencephalopathy (PML).
- History of stroke, seizure, dementia, Parkinson's disease, cerebellar diseases, psychosis, aphasia, and any other neurologic disorder that is of a nature and severity that the investigator considers would increase the risk for the subject.
- Cardiac ejection fraction ≤ 40%.
Key Trial Info
Start Date :
September 25 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT06588491
Start Date
September 25 2024
End Date
December 1 2026
Last Update
December 22 2025
Active Locations (3)
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1
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States, 80045
2
Mayo Clinic
Rochester, Minnesota, United States, 55905
3
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107