๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-08-13

A Study Evaluating the Safety and Efficacy of KITE-363 in Relapsed/Refractory Autoimmune Neurologic Diseases (NCT07304154)

๐ŸŸข Recruiting Phase1 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Kite, A Gilead Company

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

This study will have two Phases: Phase 1a and Phase 1b. The goals of this clinical study are to learn more about the study drug KITE-363, by evaluating its safety, tolerability and efficacy in participants with relapsed/refractory autoimmune neurologic diseases. The primary objectives of this study are: * To evaluate the safety and tolerability of KITE-363 in participants with autoimmune neurologic diseases * To determine the recommended dose for Phase 1b. * To evaluate the preliminary efficacy of KITE-363 in participants with autoimmune neurologic diseases.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (21 items) and avoid the listed exclusions (9 items).

Location: Hoag Memorial Hospital Presbyterian โ€” Newport Beach, California

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

Instant Checklist

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).

Usually NOT eligible if any of the following apply:

  • Exclusion Criteria for MS:
  • Cohort 1 or 2; inability to complete 9-hole Peg Test (9-HPT) in \< 240 seconds and Timed 25 foot Walk (T25FW) \< 150 seconds
  • History of hypersensitivity to parenteral administration of gadolinium-based contrast agents
  • Any renal condition that would preclude the administration of gadolinium (for the relapsing forms of MS and progressive forms of MS)
  • Any contraindication to lumbar puncture (LP) (for the relapsing forms of MS and progressive forms of MS) Exclusion Criteria for MG:
  • Current myasthenic crisis not effectively controlled within 2 weeks before enrollment
  • Thymectomy performed within 12 months of baseline Exclusion Criteria for CIDP:
  • Pure sensory CIDP and focal CIDP
  • Polyneuropathy of other causes Note: Other protocol defined Inclusion/Exclusion criteria may apply.

๐Ÿ” Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

๐Ÿ“ All Participating Trial Locations (8 Sites)

  • Hoag Memorial Hospital Presbyterian โ€” Newport Beach, California
  • Stanford Neuroscience Health Center โ€” Palo Alto, California
  • Columbia University Irving Medical Center โ€” New York, New York
  • LDS Hospital - Intermountain Health โ€” Salt Lake City, Utah
  • Fred Hutchinson Cancer Center โ€” Seattle, Washington
  • Concord Repatriation General Hospital โ€” Sydney, New South Wales
  • Corner Hawkesbury Road and Darcy Road โ€” Westmead, New South Wales
  • Jewish General Hospital โ€” Montreal,

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›๏ธ View Official NIH Record โ†—