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KITE-363 for Autoimmune Neurologic Diseases

This study is testing a treatment called KITE-363 for people with certain autoimmune neurologic diseases, including Chronic Inflammatory Demyelinating Polyneuropathy, Myasthenia Gravis, and Multiple Sclerosis. KITE-363 is a type of cell therapy where your own T cells (a type of immune cell) are specially modified and then given back to you through an IV. You would also receive two other medications, Fludarabine and Cyclophosphamide, given intravenously. The main goals are to see how safe KITE-363 is, how well people tolerate it, and if it helps improve these conditions. The study is looking for participants aged 18 to 75 years old who have been diagnosed with these conditions, including specific types of Multiple Sclerosis.

Study design
This interventional study has two phases, 1a and 1b, and plans to enroll 52 participants. It is designed to evaluate the safety, tolerability, and preliminary effectiveness of KITE-363.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be monitored for treatment-emergent adverse events (side effects) for up to 2 years after receiving KITE-363.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07304154

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

Recruiting
PHASE1Ages 18–75InterventionalTreatment
Kite, A Gilead Company
~52 participants
Updated 2026-08-14 on ClinicalTrials.gov
What's tested:KITE-363FludarabineCyclophosphamide

At a glance

Recruiting sites
8 of 8 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Phase 1a: Percentage of Participants Experiencing Treatment-emergent Adverse Event (TEAEs)
Measured over Up to 2 years
+7 more outcomes measured

Conditions

Chronic Inflammatory Demyelinating Polyneuropathy
Myasthenia Gravis
Multiple Sclerosis

Explore related trials

Chronic Inflammatory Demyelinating PolyneuropathyMultiple SclerosisMyasthenia Gravis

Where it's being run

8 sites across 6 states
California2
New South Wales2
New York1
Utah1
Washington1
Canada1

Study leadership

  • Kite Study Director · STUDY_DIRECTOR · Kite, A Gilead Company

Who to contact

Medical Information
[email protected]
844-454-5483(1-844-454-KITE)
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Reproductive status-related eligibility and contraception requirements:
Participants must agree to use protocol-specified method(s) of contraception where applicable
Diagnosed with MS according to the 2017 revision of the McDonald diagnostic criteria
Inadequate response to previous therapies is defined as evidence of breakthrough disease activity within 12 months prior to screening while on high efficacy disease-modifying therapy (DMT) OR Inadequate response to previous therapies defined as intolerance to ≥ 2 DMTs due to side effects prohibiting the chronic use of the DMT.
Expanded Disability Status Scale (EDSS) 0 to 5.5
Inadequate response to previous therapies is defined as evidence of disease progression within 12 months prior to screening despite standard of care therapy for naSPMS or despite ocrelizumab, where available, for PPMS
Absence of clinical relapses for at least 24 months
No evidence of Gadolinium enhancing (GadE+) on magnetic resonance imaging (MRI) brain at screening or baseline
EDSS of 3 to 6.5 who are ambulatory
Documentation of autoantibodies against acetylcholine receptor (AChR), muscle-specific kinase (MuSK), or low-density lipoprotein receptor-related protein 4 (LRP4)
Diagnosis of MG with generalized weakness meeting criteria as defined by the Myasthenia Gravis Foundation of American (MGFA) classification of II- IV at screening
Myasthenia Gravis Activities of Daily Living (MG-ADL) score ≥ 6 (\> 50% of the total score due to non-ocular symptoms)
Quantitative Myasthenia Gravis (QMG) score ≥ 10
Inadequate response to previous therapies while taking at least 2 classes of immunosuppressants (ie, steroids, azathioprine (AZA), mycophenolate mofetil (MMF), intravenous immunoglobulin (IVIg), biologics (eg, rituximab, anti-neonatal fragment crystallizable (Fc) receptor (FcRN) class, and anti-complement class))
Thymectomy allowed if completed ≥ 12 months prior to screening
Probable or definite CIDP as defined by the 2010 European Federation of Neurological Societies/Peripheral Nerve Society (EFNS/PNS) criteria, relapsing or progressive forms
CIDP Disease Activity Status (CDAS) score ≥ 3 at screening
Inflammatory neuropathy cause and treatment (INCAT) score ≥ 3
Inadequate response to previous therapies despite standard of care therapy (ie, steroids, IVIg, subcutaneous immunoglobulin (SCIg), plasmapheresis exchange (PLEX), rituximab, or anti FcRN) OR Unable to tolerate standard of care due to side effects with ongoing disease activity
Except for nodal/paranodal CIDP, historical documentation of objective improvement in the past 24 months while on IVIg, SCIg, PLEX, or anti-FcRN OR Historical documentation of objective disease worsening in the past 24 months when IVIg, SCIg, PLEX, or anti-FcRN has been reduced or interrupted

Exclusion

History or presence of central nervous system (CNS) or peripheral nervous system disorders before enrollment that may impact cognition, strength, or cause weakness
History of autologous or allogeneic stem cell transplant and/or organ transplant
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)
Current myasthenic crisis not effectively controlled within 2 weeks before enrollment
Thymectomy performed within 12 months of baseline
Pure sensory CIDP and focal CIDP
Polyneuropathy of other causes

What this trial measures

  • Phase 1a: Percentage of Participants Experiencing Treatment-emergent Adverse Event (TEAEs)Up to 2 years
  • Phase 1a: Percentage of Participants Experiencing Dose-limiting Toxicities (DLTs) After the Infusion of KITE-363Up to 28 days
  • Phase 1b: (All Cohorts) Percentage of Participants Experiencing TEAEsUp to 2 years
  • Phase 1b: Relapsing Forms of MS (RRMS) and (aSPMS): Number of New T1 Gadolinium Enhancing (GadE+) Lesions on Magnetic Resonance Imaging (MRI) at Week 12Week 12

    This will be reported in participants with relapsing forms of Multiple Sclerosis MS (RRMS) and (aSPMS).

  • Phase 1b: Relapsing Forms of MS (RRMS and aSPMS): Number of New and/or Enlarging T2 Lesions on MRI at Week 12Week 12
  • Phase 1b: Progressive Forms of MS (PPMS) and (naSPMS): Time to Onset of Confirmed Disability Progression Over 12 Weeks (CDP-12)Up to 2 years
  • Phase 1b: Myasthenia Gravis (MG): Proportion of Participants of MG Activities of Daily Living (MG-ADL) RespondersUp to Week 24

    The MG-ADL is a scale to measure the functional impact of MG on daily activities. The total score ranges from 0 to 24, with higher scores indicating greater disability and disease burden.

  • Phase 1b: Chronic Inflammatory Demyelinating Polyneuropathy (CIDP): Proportion of Participants with Confirmed Evidence of Clinical Improvement at Week 24Week 24

    Clinical improvement will be analyzed using inflammatory neuropathy cause and treatment (INCAT) scale. The INCAT score is a clinician administered tool used to assess functional disability in participants with CIDP. The total scores range from 0 to 10, higher scores indicating greater disability and lower score would indicate clinical improvement.