RecruitingPhase 1

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 75 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests KITE-363 for autoimmune nerve diseases, where the immune system attacks the body's own nervous system. It is for people whose disease has returned or has not responded well to treatment. Researchers will check safety, side effects, the best dose for the next study phase, and how well it works.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Agree to use the study's required birth control methods, if needed.
  • For multiple sclerosis (MS): Have a diagnosis that meets the study's rules.
  • For MS with flare-ups: Have disease activity in the past 12 months while on a highly effective MS drug, or be unable to tolerate at least 2 MS drugs. Your EDSS disability score must be 0–5.5.
  • For steadily worsening MS: Have worsened in the past 12 months despite required treatment. You must be able to walk, have an EDSS disability score of 3–6.5, have no flare-ups for 24 months, and have no active spots seen with contrast dye on the required brain MRI scans.
  • For myasthenia gravis (MG), a disease that causes muscle weakness: Have one of the required immune proteins in your blood and weakness beyond the eye muscles. You must meet the study's weakness and daily activity score limits.
  • For MG: Have a poor response while taking at least 2 types of drugs that reduce immune activity. Any surgery to remove the thymus gland must have been at least 12 months before screening.
  • For CIDP, a disease that damages the protective covering of nerves: Have probable or confirmed disease that returns or worsens. Meet the study's disease activity and disability score limits, and have a poor response to usual treatment or side effects that prevent its use while disease stays active.
  • For most forms of CIDP: Have records from the past 24 months showing improvement with certain treatments, or worsening when those treatments were reduced or stopped.

Who can't join

  • A past or current brain, spinal cord, or nerve disorder that may affect thinking or strength, or cause weakness.
  • A past stem cell or organ transplant.
  • For MS groups 1 and 2: Cannot meet the required times for a hand test and a 25-foot walking test.
  • For MS: A past allergic reaction to injected gadolinium MRI dye, or a kidney problem that prevents its use.
  • For MS: A medical reason you cannot safely have a spinal tap, a test that collects fluid from around the spinal cord.
  • For MG: A current severe flare-up that was not effectively controlled within 2 weeks before joining.
  • For MG: Surgery to remove the thymus gland within 12 months before the study's starting assessment.
  • For CIDP: Disease that affects only feeling, disease limited to one area, or nerve damage from another cause.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Key Inclusion Criteria: * 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 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 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 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-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. 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 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 * History of hemophagocytic lymphohistiocytosis (HLH) or macrophage activation syndrome (MAS) 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.

Study sites (5)

CA

NY

UT

WA