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Tests treatment safety and results for Chronic Inflammatory Demyelinating Polyneuropathy
Official title A Study Evaluating the Safety and Efficacy of KITE-363 in Relapsed/Refractory Autoimmune Neurologic Diseases
ClinicalTrials.gov ID: NCT07304154
What this study is testing
What is KITE-363?
KITE-363 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for chronic inflammatory demyelinating polyneuropathy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Reproductive status-related eligibility and contraception requirements:
- Participants must agree to use protocol-specified method(s) of contraception where applicable for multiple sclerosis (MS): MS (Relapsing and...
- Diagnosed with MS according to the 2017 revision of the McDonald diagnostic criteria Relapsing forms of MS (relapsing-remitting multiple sclerosis...
- Inadequate response to previous therapies is defined as evidence of breakthrough disease activity within 12 months prior to screening while on high...
- Expanded Disability Status Scale (EDSS) 0 to 5.5 Progressive forms of MS (primary-progressive multiple sclerosis (PPMS) and non-active...
You likely can't join if
- History or presence of central nervous system (CNS) or peripheral nervous system disorders before enrollment that may impact cognition, strength, or...
- 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:
See the full eligibility criteria
- Reproductive status-related eligibility and contraception requirements:
- Participants must agree to use protocol-specified method(s) of contraception where applicable 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 how well it works disease-modifying therapy (DMT) OR Inadequate...
- 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 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...
- Thymectomy allowed if completed ≥ 12 months prior to screening 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Palo Alto, California, United States
- New York, New York, United States
- Salt Lake City, Utah, United States
- Seattle, Washington, United States
- Sydney, New South Wales, Australia
- Westmead, New South Wales, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Palo Alto, California, United States; New York, New York, United States; Salt Lake City, Utah, United States; Seattle, Washington, United States; Sydney, New South Wales, Australia; Westmead, New South Wales, Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.