๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-08-06

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

Phase 1, Open-Label, Single Center Study of KYV-101, an Autologous Fully-Human Anti-CD19 Chimeric Antigen Receptor T Cell (CD19 CAR T) Therapy, in Participants With Treatment Refractory Progressive Multiple Sclerosis

๐Ÿ”ต Active, Not Recruiting Phase1 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Bruce Cree

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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 join: Review the eligibility criteria below.

Location: University of California, San Francisco, Multiple Sclerosis Center โ€” San Francisco, California

Age range: 25 Years to 70 Years

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (1 Sites)

  • University of California, San Francisco, Multiple Sclerosis Center โ€” San Francisco, California

๐Ÿ’ฐ 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 ยง 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.

๐Ÿ’ก 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.
๐Ÿ›๏ธ View Official NIH Record โ†—