A Study of KYV-101, a CD19 CAR T Cell Therapy, in Participants With Treatment Refractory Progressive Multiple Sclerosis (NCT06451159)

🧪 Interventions in This Study

• KYV-101 (Biological) - 0.33 ×10^8 cells (BIOLOGICAL)
• KYV-101 (Biological) - 1 ×10^8 cells (BIOLOGICAL)
• Chemotherapy: cyclophosphamide (CYC) (DRUG)
• Chemotherapy: fludarabine (FLU) (DRUG)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. Participant must sign a written informed consent form (ICF) prior to any screening procedures.
2. Participant must be 25-70 years of age (inclusive).
3. Clinical diagnosis of MS with evidence of primary or secondary progressive MS based on 2017 International Panel Criteria (Thompson 2018).
4. Historical documented presence of CSF restricted OCBs or elevated IgG Index (reconfirmed on screening).
5. Expanded disability status score (EDSS) score 3.0-7.0
6. 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).
7. Adequate organ function as per below: Hematology- Hemoglobin \> 8 g/dl (without prior red blood cell transfusion within 7 days before the laboratory test) Platelets \> 50,000/µL (without transfusion support within 7 days before the laboratory test) Absolute Neutrophil Count (ANC) \>1,000/µL (prior growth factor support is permitted but must be without support in the 7 days prior to the laboratory test) Absolute Lymphocyte Count (ALC) \> 500/µL IgG \> 600 mg/dL Hepatic- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 1.5 ×upper limit of normal (ULN) Total bilirubin ≤ 1.5 mg/dl, except with Gilbert's syndrome Renal- estimated Glomerular Filtration Rate (eGFR) \> 45 mL/min/1.73 m2 (measured by Chronic Kidney Disease (CKD) - Epidemiology Collaboration (EPI) 2021 equation)
8. 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.
9. Participants are recommended to be up to date on other recommended vaccinations, including against Coronavirus Disease (COVID-19)/ Severe Acute Respiratory Syndrome (SARS) Coronavirus 2 (CoV-2), per Centers for Disease Control and Prevention or institutional guidelines for immune-compromised individuals.
10. Women of childbearing potential must have a negative pregnancy test at screening, prior to apheresis, and prior to lymphodepletion chemotherapy using a highly sensitive serum pregnancy test (β- human Chorionic Gonadotropin (hCG)). A woman of childbearing potential is defined as a sexually mature woman who has not undergone a hysterectomy or tubal ligation or who has not been naturally postmenopausal for at least 24 consecutive months.
11. Female participants of childbearing potential who have a fertile male sexual partner must agree to use a highly effective method of contraception (failure rate of \< 1% per year when used consistently and correctly) from the time of signing the ICF until 24 months after the KYV-101 infusion. Examples of highly effective method of contraception include:
12. Established use of hormonal methods of contraception associated with inhibition of ovulation (e.g. oral, inserted, injected, implanted, transdermal), provided the participant or male participant's female partner plans to remain on the same treatment throughout the entire study and has been using that hormonal contraceptive for adequate time to ensure effectiveness.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

• University of California, San Francisco, Multiple Sclerosis Center — San Francisco, California

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

More studies in Progressive Multiple Sclerosis

• Open-label, Multi-center, Phase I/II Study to Assess Safety, Disease Progression and Cellular Kinetics Following YTB323 Administration in Participants With Non-active Progressive Multiple Sclerosis (PMS) — Darlinghurst, New South Wales
• Bringing the Outdoors In: Virtual Nature Walks for Depression in Multiple Sclerosis (MS) Patients — Ann Arbor, Michigan
• Obe-cel in Refractory Progressive Forms of Multiple Sclerosis — Redwood City, California
• ABA-101 in Participants With Progressive Multiple Sclerosis — Baltimore, Maryland

Explore by condition: All Progressive Multiple Sclerosis clinical trials

💡 How to Participate

1. Check the checklist above to see if you may qualify.
2. Review the official NIH record below to find the coordinating site.
3. Ask about the visit schedule, what is covered at no cost, and any travel support.
4. Confirm with your own doctor before making a decision.