NCT07304154 A Study Evaluating the Safety and Efficacy of KITE-363 in Relapsed/Refractory Autoimmune Neurologic Diseases
| NCT ID | NCT07304154 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Kite, A Gilead Company |
| Condition | Chronic Inflammatory Demyelinating Polyneuropathy |
| Study Type | INTERVENTIONAL |
| Enrollment | 52 participants |
| Start Date | 2026-04-10 |
| Primary Completion | 2029-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 52 participants in total. It began in 2026-04-10 with a primary completion date of 2029-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Key Inclusion Criteria: * Reproductive status-related eligibility and contraception requirements: * Participants must agree to use protocol-specified method(s) of contraception where applicable Inclusion Criteria for multiple sclerosis (MS): MS (Relapsing and progressive forms): * Diagnosed with MS according to the 2017 revision of the McDonald diagnostic criteria Relapsing forms of MS (relapsing-remitting multiple sclerosis (RRMS), active secondary-progressive multiple sclerosis (aSPMS)): * 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 Progressive forms of MS (primary-progressive multiple sclerosis (PPMS) and non-active secondary-progressive multiple sclerosis (naSPMS)): * 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 Inclusion Criteria for myasthenia gravis (MG): * 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 Inclusion Criteria for chronic inflammatory demyelinating polyneuropathy (CIDP): * 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 Key Exclusion Criteria: * 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 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.
Contact & Investigator
Kite Study Director
STUDY DIRECTOR
Kite, A Gilead Company
Frequently Asked Questions
Who can join the NCT07304154 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Chronic Inflammatory Demyelinating Polyneuropathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07304154 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07304154 currently recruiting?
Yes, NCT07304154 is actively recruiting participants. Contact the research team at medinfo@kitepharma.com for enrollment information.
Where is the NCT07304154 trial being conducted?
This trial is being conducted at Salt Lake City, United States, Seattle, United States, Sydney, Australia.
Who is sponsoring the NCT07304154 clinical trial?
NCT07304154 is sponsored by Kite, A Gilead Company. The principal investigator is Kite Study Director at Kite, A Gilead Company. The trial plans to enroll 52 participants.