Engineered immune cells take on multiple sclerosis and other nerve diseases
NCT ID NCT07304154
First seen Jun 27, 2026 · Last updated Aug 14, 2026 · Updated 3 times
Summary
This early-phase trial is testing a new treatment called KITE-363 for people with certain autoimmune nerve diseases that have not responded to standard therapies. KITE-363 is a type of CAR T-cell therapy that uses a patient's own immune cells, modified to target and attack faulty immune cells. The study includes people with multiple sclerosis, myasthenia gravis, and chronic inflammatory demyelinating polyneuropathy, and aims to check safety and find the right dose.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- KITE-363 (a type of CAR T-cell therapy that targets CD19 and CD20 proteins on immune cells)
- What this could lead to
- If successful, this could point toward a new treatment option for people with hard-to-treat autoimmune neurologic diseases like multiple sclerosis, myasthenia gravis, and chronic inflammatory demyelinating polyneuropathy.
- What could go wrong
- This is an early Phase 1 trial with only 52 participants, so safety and effectiveness are not yet proven. CAR T-cell therapy can cause serious side effects like cytokine release syndrome and nervous system problems.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 52 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2026
- Expected to finish
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Jun 2029
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
8 sites in 3 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
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Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
Locations
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Columbia University Irving Medical Center
RECRUITINGNew York, New York, 10032, United States
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Concord Repatriation General Hospital
RECRUITINGSydney, New South Wales, 2139, Australia
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Corner Hawkesbury Road and Darcy Road
RECRUITINGWestmead, New South Wales, 2145, Australia
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Fred Hutchinson Cancer Center
RECRUITINGSeattle, Washington, 98109, United States
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Hoag Memorial Hospital Presbyterian
RECRUITINGNewport Beach, California, 92663, United States
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Jewish General Hospital
RECRUITINGMontreal, H3T 1E2, Canada
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LDS Hospital - Intermountain Health
RECRUITINGSalt Lake City, Utah, 84143, United States
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Stanford Neuroscience Health Center
RECRUITINGPalo Alto, California, 94304, United States
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