No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
52 (estimated)
Sponsor
Kite, A Gilead Company · Industry
Who this trial is looking for
This trial is looking for people with conditions like multiple sclerosis, myasthenia gravis, or chronic inflammatory demyelinating polyneuropathy. Participants will help researchers understand the safety and effectiveness of a new treatment called KITE-363.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with multiple sclerosis, myasthenia gravis, or chronic inflammatory demyelinating polyneuropathy.
I have not responded well to previous treatments.
I am using specified methods of contraception if needed.
You may not be able to join if
I have had central or peripheral nervous system disorders that affect strength or cognition.
I have had a stem cell or organ transplant.
I cannot complete specific physical tests required for the study.
I am currently in a myasthenic crisis.
I have had a thymectomy in the last 12 months.
I have certain types of CIDP that are not included in the study.
I have a renal condition that affects the use of gadolinium contrast agents.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 neurolo…
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.
Trial Locations
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Status
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 w…
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.
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