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Experimental CAR T-Cell therapy targets rare stiff person syndrome

NCT ID NCT06588491

Disease control Sponsor: Kyverna Therapeutics Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 24, 2026 · Updated 3 times

Summary

This phase 2 trial is testing a new treatment called KYV-101 for people with stiff person syndrome (SPS) that hasn't improved with standard therapies. The treatment uses a patient's own immune cells, modified to target and attack certain immune cells that may be causing the disease. The study will enroll 25 participants to see if the therapy can improve walking speed and reduce symptoms, while also monitoring for side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
KYV-101 (a type of CAR T-cell therapy made from the patient's own immune cells, targeting CD19)
What this could lead to
If successful, this could offer a new treatment option for people with stiff person syndrome that hasn't responded to other therapies, potentially improving mobility and reducing symptoms.
What could go wrong
This is an early-phase trial with only 25 participants, so results may not apply to everyone. CAR T-cell therapy can cause serious side effects like cytokine release syndrome and neurological problems.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

27 people

The number who actually took part.

Started

Sep 2024

Finished

Jun 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: * 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 Criteria: * 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%.

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Conditions

The condition(s) this trial relates to.

coxopodopatellar syndrome stiff-person syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

SPS Stiff person syndrome

Contacts and locations

Locations

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107, United States

  • University of Colorado Anschutz Medical Campus

    Aurora, Colorado, 80045, United States

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