Investigating a new therapy to help patients living with Stiff-Person Syndrome (SPS)
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SPS is a rare, chronic, progressive disease
of the nervous system that can affect nerves in the body. In SPS, the braking
system of the nerves fails. People with SPS commonly experience muscle stiffness
in the arms, legs, and trunk and painful spasms that can worsen over time.
Other symptoms may include unsteady walking and falls.
SPS
can start at any age but is more common when people are in their 30s and 40s.
It is twice more common in women than in men.
1. Treat symptoms like muscle relaxers
2. Treat pain
like over-the-counter pain relievers
3. Treat
the immune system, like IVIg (intravenous immunoglobulin)
The goal of treatment
is to reduce spasms, stiffness, and pain. Your doctor can discuss with you the
variety of treatment options for SPS, including the benefits and risks of such
options.
KYV-101 is an investigational CAR T-cell therapy used in over 50 patients. KYV-101 works with your immune system to target the cells that harm your body, including unhealthy B cells that may contribute to disease activity in SPS.
This is the first study using KYV-101 in SPS,
but 3 patients with SPS have been treated with KYV-101. Patients with Lupus Nephritis,
Myasthenia Gravis, Systemic Sclerosis (Scleroderma), and Multiple Sclerosis
have also been treated with KYV-101.
You are 18 to 75 years old.
You have been diagnosed with SPS according to specific criteria.
Your disease is active, and you have tried previous treatments, but you did not get better.
You are up to date on vaccinations.
This list does not include all the trial participation criteria and additional criteria may apply.
If you are interested in taking part in the trial,
your doctor can refer you to a trial site. The trial doctor will assess you to confirm your eligibility for trial participation. This may include performing additional tests. The trial doctor will
also explain the detailed criteria for participating. This trial has multiple
sites in the United States. You may need to travel if you do not live near a
trial site.
Participant Accommodations: We aim to
make every participant’s KYSA-8 clinical trial experience as easy as possible.
Accommodations for trial participation may be available and may include travel
and caregiver support.
If you are selected to participate, one of the doctors running the trial
(or someone on their behalf) will talk with you about what you can expect as a
participant in the trial so that you understand and are comfortable with what
it means to take part. This is called informed consent.
If you are able to enroll in the trial, these are the key steps you will be involved in:
CAR T-cell therapies can be associated with cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS), which may be potentially serious or life-threatening but generally resolve within the first month after treatment.
People receiving this treatment are always in the care of a doctor, who monitors them closely for these side effects and can treat their symptoms to help prevent their worsening.
Patient Advocacy Groups
Patient advocacy groups can offer additional educational resources.*
The SPS Research Foundation (The SPSRF) is the leading organization advancing awareness for SPS. In addition to supporting and empowering patients and families, The SPSRF fosters collaboration across medical and research communities and is dedicated to raising funds that support innovative SPS research.
*Note that these links are provided for informational purposes only and its content is not necessarily supported or endorsed by Kyverna Therapeutics.
The KYSA-8 clinical trial aims to show efficacy and confirm safety of KYV-101, a CAR T-cell therapy, as a potential treatment for people living with SPS.
The KYSA-8 clinical trial is sponsored by Kyverna Therapeutics, a company dedicated to developing therapies to help reset the immune system and help eliminate the need for long-term or suboptimal therapies.
•
Phase 1: Safety. In a Phase 1 clinical trial, doctors want to understand if a treatment is safe and well tolerated in humans. Phase 1 trials are the first stage of human clinical trials and usually involve only a small number of people.
• Phase 2: Efficacy. In a Phase 2 clinical trials expand the study to a larger group of individuals to assess the treatment’s effectiveness and further evaluate its safety.
To ensure that clinical trials are conducted safely, doctors take safety precautions which include:
• Informed consent : Participation in the trials is voluntary. Participants in a clinical trial are to provide informed consent before they can participate in the study. This means that participants will be given information about the clinical trial, including the risks and benefits, before the participants indicate if they want to join the study.
• Data safety monitoring : An independent data safety monitoring board (DSMB) is a group of independent experts who review the data collected in a clinical trial on a regular basis. The DSMB is responsible for ensuring that the clinical trial is being conducted safely and that the participants are not being put at risk.
• Side effect reporting : All side effects that occur in a clinical trial must be reported to the clinical trial team. An adverse event is any unwanted or unexpected medical occurrence that happens to a participant during a clinical trial.
• Withdrawal from the clinical trial : Participants in a clinical trial have the right to withdraw at any time.
No. All participants will receive KYV-101 and will be closely monitored by a team of healthcare professionals.
Yes, to protect your privacy, steps taken by the clinical trial team will include:
• Use of codes or pseudonyms instead of your real name.
• Secure storage of your data without access by unauthorized individuals.
• Requiring clinical trial investigators to sign confidentiality agreements.
You will also have the right to withdraw from the study at any time. Data that was collected by your study doctor will still be able to be used by the sponsor.
It is believed that it is an autoimmune disorder caused by a type of cell called B cells.
This is the first study using KYV-101 in SPS, but several patients with SPS have been treated with KYV-101. Patients with Lupus Nephritis, Myasthenia Gravis, Systemic Sclerosis (Scleroderma), and Multiple Sclerosis have also been treated with KYV-101.
