Actively Recruiting
A Study Evaluating the Safety and Efficacy of KITE-363 in Relapsed/Refractory Autoimmune Neurologic Diseases
Led by Kite, A Gilead Company · Updated on 2026-04-21
52
Participants Needed
3
Research Sites
164 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study Evaluating the Safety and Efficacy of KITE-363 in Relapsed/Refractory Autoimmune Neurologic Diseases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants aged 18 to 75 years
- Agreement to use specified contraception methods where applicable
- Diagnosed with multiple sclerosis (MS) according to the 2017 McDonald criteria
- For relapsing forms of MS: evidence of breakthrough disease activity on high efficacy therapy within 12 months or intolerance to two or more disease-modifying therapies
- Expanded Disability Status Scale (EDSS) 0 to 5.5 for relapsing MS
- For progressive MS: disease progression despite standard care, no clinical relapses for at least 24 months, no gadolinium enhancing lesions on MRI, EDSS 3 to 6.5 and ambulatory
- For myasthenia gravis (MG): documented autoantibodies, MGFA classification II-IV, MG-ADL score ≥6, QMG score ≥10
- Inadequate response to at least two classes of immunosuppressants in MG
- Thymectomy completed at least 12 months prior for MG
- For chronic inflammatory demyelinating polyneuropathy (CIDP): probable or definite CIDP as per 2010 EFNS/PNS criteria, CDAS score ≥3, INCAT score ≥3
- Inadequate response or intolerance to standard therapies for CIDP with ongoing disease activity
- Historical documentation of objective disease improvement or worsening related to immunoglobulin or anti-FcRN therapy in CIDP
You will not qualify if you...
- History or presence of CNS or peripheral nervous system disorders impacting cognition, strength, or causing weakness
- Prior autologous or allogeneic stem cell or organ transplant
- For MS: inability to complete 9-Hole Peg Test in under 240 seconds and Timed 25-foot Walk in under 150 seconds
- Hypersensitivity to gadolinium contrast agents
- Renal conditions preventing gadolinium administration
- Contraindications to lumbar puncture for MS participants
- For MG: current myasthenic crisis not controlled within 2 weeks before enrollment
- Thymectomy performed less than 12 months before baseline
- For CIDP: pure sensory or focal CIDP
- Polyneuropathy due to other causes
AI-Screening
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Trial Site Locations
Total: 3 locations
1
LDS Hospital - Intermountain Health
Salt Lake City, Utah, United States, 84143
Actively Recruiting
2
Fred Hutchinson Cancer Center
Seattle, Washington, United States, 98109
Actively Recruiting
3
Concord Repatriation General Hospital
Sydney, New South Wales, Australia, 2139
Actively Recruiting
Research Team
M
Medical Information
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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