Actively Recruiting
A Phase 1 Study Evaluating the Safety and Efficacy of KITE-363, an Autologous CAR T-cell Therapy, in Relapsed/Refractory Autoimmune Neurologic Diseases
Led by Kite, A Gilead Company · Updated on 2026-06-08
52
Participants Needed
4
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating KITE-363, a CAR T-cell therapy, in adults with relapsed or refractory autoimmune neurologic diseases including multiple sclerosis (MS), myasthenia gravis (MG), and chronic inflammatory demyelinating polyneuropathy (CIDP). This Phase 1 study aims to assess the safety, tolerability, and preliminary effectiveness of KITE-363 while determining the best dose for further study. The trial includes participants with relapsing and progressive forms of MS, MG with generalized weakness, and CIDP with ongoing disease activity despite prior treatments. Participants will receive lymphodepleting chemotherapy with cyclophosphamide and fludarabine, followed by a single intravenous infusion of their own T cells modified to target disease markers (KITE-363). The study has two parts: Phase 1a involves dose escalation to find the recommended dose, and Phase 1b involves dose expansion using the chosen dose. Different dose levels will be tested sequentially in Phase 1a, while Phase 1b will evaluate the recommended dose in participants with the autoimmune neurologic diseases. Throughout the study, participants will be monitored for treatment-emergent side effects and dose-limiting toxicities for up to two years. Various clinical and imaging assessments will be performed, including MRI scans for MS, symptom and disability scores for MG and CIDP, and measurements of immune cells and biomarkers in the blood. Safety and efficacy will be evaluated at specific time points such as 12 and 24 weeks, with long-term follow-up extending to two years after treatment.
CONDITIONS
Brief 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...
- Adults aged 18 to 75 years
- Diagnosed with relapsed or progressive multiple sclerosis according to 2017 McDonald criteria
- For relapsing MS: inadequate response to prior high efficacy therapy or intolerance to at least 2 disease-modifying therapies
- For progressive MS: disease progression despite standard care, no relapses for 24 months, no gadolinium-enhancing lesions, ambulatory with EDSS 3 to 6.5
- Diagnosis of myasthenia gravis with documented autoantibodies and MGFA class II-IV
- MG-ADL score ≥ 6 and QMG score ≥ 10
- Inadequate response to at least 2 classes of immunosuppressants for MG
- Probable or definite CIDP with CDAS score ≥ 3 and INCAT score ≥ 3
- Inadequate response or intolerance to standard CIDP therapies
- Agreement to use protocol-specified contraception methods if applicable
You will not qualify if you...
- History or presence of CNS or peripheral nervous system disorders affecting cognition or strength unrelated to autoimmune disease
- Previous 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 or renal conditions preventing its use
- Contraindications to lumbar puncture for MS participants
- For MG: uncontrolled myasthenic crisis within 2 weeks before enrollment
- Thymectomy within 12 months prior to baseline
- For CIDP: pure sensory or focal CIDP
- Polyneuropathy from other causes
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 28 days
Participants receive lymphodepleting chemotherapy with cyclophosphamide and fludarabine followed by a single infusion of KITE-363 CAR T cells.
1 to 2 visits for chemotherapy administration and 1 infusion visit
Duration - Up to 2 years
Participants are monitored for safety and efficacy outcomes, including disease progression and clinical improvement, for up to 2 years after treatment.
Regular follow-up visits over 2 years
Trial Site Locations
Total: 4 locations
1
Stanford Neuroscience Health Center
Palo Alto, California, United States, 94304
Actively Recruiting
2
LDS Hospital - Intermountain Health
Salt Lake City, Utah, United States, 84143
Actively Recruiting
3
Fred Hutchinson Cancer Center
Seattle, Washington, United States, 98109
Actively Recruiting
4
Concord Repatriation General Hospital
Sydney, New South Wales, Australia, 2139
Actively Recruiting
Research Team
M
Medical Information
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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