Study of KITE-363 in Participants With Autoimmune Neurologic Diseases That Did Not Respond to Usual Treatment

Study acronym: HERMOSA-2
StatusRecruiting
PhasePhase 1
Started

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Trial flagged as At Risk
Primary endpoint reworded 3 of 8 changed
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Record History

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  1. Primary endpoint(s) modified Show 6 more changesShow less
    • Trial arms changed: 2 → 3
    • Enrollment target: 52 to 57
    • Study sites: 8 to 10
    • Eligibility criteria expanded, about 192 words
    • Secondary endpoints: 42 to 48
    • Study title expanded, about 2 words
  2. Study sites: 6 to 8v7
  3. Study sites: 4 to 6v6
  4. Study sites: 3 to 4v5
  5. Recruitment opened
    • Trial sites expanded: 0 → 3 locations
    • Start date changed from estimate of Mar 2026 to Apr 10, 2026
    v4
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  1. Start date: Feb 2026 to Mar 2026v3
  2. Start date: Jan 2026 to Feb 2026
    • Secondary endpoints: details revised at 1 of 42 entries
    v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 safety and preliminary efficacy of KITE-363 in participants with autoimmune neurologic diseases
Trial Details
NCT Number NCT07304154
Lead Sponsor Kite, A Gilead Company
Conditions
(from sponsor)		 Chronic Inflammatory Demyelinating Polyneuropathy, Myasthenia Gravis, Multiple Sclerosis
Related terms Multiple Sclerosis, Myasthenia Gravis, Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
Enrollment 57 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov