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

A vizsgálat adatai

Ki végzi

Kite, A Gilead Company

Azonosító

NCT07304154

A regiszteradat frissítve

2026. október 19.

Eredeti leírás

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.A teljes eredeti leírásKevesebb

A Phase 1, Open-label, Multiregional, Multicenter, Basket Study Evaluating the Safety and Efficacy of KITE-363, an Autologous Anti-CD19/CD20 CAR T-cell Therapy in Participants With Relapsed/Refractory Autoimmune Neurologic Diseases

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

Bevonási feltételek: Age 18 through 65 for relapsing forms of MS, 18 through 75 for progressive forms of MS, above 18 years of age for MG and CIDP; Reproductive status-related eligibility and contraception requirements:; Individuals must agree to use protocol-specified method(s) of contraception where applicable; 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 6.0; 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; 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-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. Individuals with confirmed IgG4 paranodal antibodies (eg, NF155, CNTN1, Caspr1) are eligible if they meet EFNS/PNS 2010 criteria; For the Phase 1b CIDP cohort, diagnosis will be confirmed by independent adjudication once the adjudication committee is established and operational; CIDP Disease Activity Status (CDAS) score ≥ 3 at screening and confirmed at the final pre treatment assessment prior to infusion; Inflammatory neuropathy cause and treatment (INCAT) score ≥ 3 at screening and confirmed at one of more protocol-defined baseline assessments during the Extended Screening Period with Observational Run-in; individuals must also continue to meet clinical eligibility criteria at the final pre-treatment assessment prior to infusion; Inadequate response to previous therapies despite adequate trial of standard of care therapy (≥ 8-12 weeks at standard dosing with stable regimen of either steroids, IVIg, SCIg, plasmapheresis exchange (PLEX), rituximab or anti-FcRN) and either failure, intolerance, or contraindication to at least one additional standard therapy (ie, steroids, IVIg, subcutaneous immunoglobulin (SCIg), plasmapheresis exchange (PLEX), rituximab, or anti FcRN), unless medically inappropriate OR Unable to tolerate standard of care resulting in discontinuation 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.

Kizáró feltételek: Current myasthenic crisis not effectively controlled within 2 weeks before enrollment; 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; History of hemophagocytic lymphohistiocytosis (HLH) or macrophage activation syndrome (MAS); 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); Cohort 1 or 2; inability to complete 9-hole Peg Test (9-HPT) in < 240 seconds and Timed 25 foot Walk (T25FW) < 150 seconds; Any contraindication to lumbar puncture (LP) (for the relapsing forms of MS and progressive forms of MS); Thymectomy performed within 12 months of baseline; Pure sensory CIDP and focal CIDP; Polyneuropathy of other causes; Note: Other protocol defined Inclusion/Exclusion criteria may apply.

ClinicalTrials.gov NCT07304154