A Study of KYV-101, a CD19 CAR T Cell Therapy, in Participants With Treatment Refractory Progress… (NCT06451159) | Clinical Trial Compass
Active — Not RecruitingPhase 1
A Study of KYV-101, a CD19 CAR T Cell Therapy, in Participants With Treatment Refractory Progressive Multiple Sclerosis
United States10 participantsStarted 2024-06-20
Plain-language summary
The goal of this study is to test a drug called KYV-101 in people who have progressive multiple sclerosis (MS) and who have not responded to standard therapies to slow disease progression. The main questions it aims to answer are:
* What is the highest therapy dose that can be given without causing harm?
* Can this therapy enter the central nervous system?
Participants will be asked to:
* Attend 14 visits plus an 8-day inpatient hospital stay over the course of 58 weeks.
* Complete apheresis and chemotherapy treatments in preparation for KVY-101 therapy.
* Undergo medical and research testing such as physical and neurological exams, MRI, lumbar puncture, blood draws, questionnaires, and vision assessments.
Who can participate
Age range
25 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Participant must sign a written informed consent form (ICF) prior to any screening procedures.
. Participant must be 25-70 years of age (inclusive).
. Clinical diagnosis of MS with evidence of primary or secondary progressive MS based on 2017 International Panel Criteria (Thompson 2018).
. Historical documented presence of CSF restricted OCBs or elevated IgG Index (reconfirmed on screening).
. Expanded disability status score (EDSS) score 3.0-7.0
. Documented evidence of clinical disability progression within the 2 years prior to inclusion, i.e. a) progression of EDSS during the past two years of at least 1 point sustained for at least 6 months if inclusion EDSS is from 3.5 to 5.5 or at least 0.5 point increase sustained for at least 6 months if inclusion EDSS is from 6 to 6.5 or b) increase of Timed Walk 25 (TW25) by at least 20% in the last two years sustained for at least 6 months or c) other well-documented objective worsening despite at least 1 year of prior treatment for progressive forms of MS (including siponimod, and/or anti- B-lymphocyte antigen (CD20) MAb).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The presence of CAR-T cells in CSF following their peak expansion in peripheral blood.
Timeframe: Screening to Week 48
2
The incidence and severity of adverse events and dose-limiting toxicities.
. Positive varicella zoster virus titer. Participants who test seronegative for varicella zoster virus IgG antibodies will be recommended to obtain vaccination prior to Investigational Product (IP) infusion.
Exclusion criteria
. MS clinical stability on Disease Modifying Therapy (DMT) therapy.
. Clinical relapse in the two years prior to study entry.
. Disease other than MS to explain the first demyelinating event; including Aquaporin-4 (AQP4) IgG or Myelin oligodendrocyte glycoprotein (MOG)-IgG seropositivity.
. Unwilling or unsafe to proceed with cerebral spinal fluid (CSF) exams based on coagulopathy or anatomy or other considerations in the judgment of the study investigator.
. Unwilling or unsafe to proceed with MRI.
. History of allogeneic or autologous stem cell transplant or solid organ transplant.
. Prior treatment CAR-T or gene therapy product directed at any target.
. Prior treatment with mitoxantrone, cladribine or alemtuzumab.