Recruiting
Phase 1

KITE-363

Sponsor:

Kite, A Gilead Company

Code:

NCT07304154

Conditions

Chronic Inflammatory Demyelinating Polyneuropathy

Myasthenia Gravis

Multiple Sclerosis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

KITE-363

Fludarabine

Cyclophosphamide

Study Details

Brief summary:

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.

Conditions

Chronic Inflammatory Demyelinating Polyneuropathy

Myasthenia Gravis

Multiple Sclerosis

Study ID

NCT07304154

Start date

Apr 10, 2026

Status verified date

Aug, 2026

Completion date

Jun, 2029

Anticipated

Primary completion date

Jun, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

52 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Phase 1a: KITE-363 (Dose Escalation)

Participants with relapsing forms of multiple sclerosis (RMS), progressive forms of multiple sclerosis (PMS), myasthenia gravis (MG), and/or chronic inflammatory demyelinating polyneuropathy (CIDP) will receive lymphodepleting chemotherapy with cyclophosphamide and fludarabine followed by infusion of KITE-363 chimeric antigen receptor (CAR) transduced autologous T cells at a single dose level, with different participants receiving sequential dose-escalation levels to find the Phase 1b recommended dose.

experimental: Phase 1b: KITE-363 (Dose Expansion)

Participants with RMS, PMS, MG, and/or CIDP will receive lymphodepleting chemotherapy with cyclophosphamide and fludarabine followed Phase 1a recommended dose of KITE-363 CAR T cells.

Interventions

KITE-363

A single infusion of CAR-transduced autologous T cells administered as intravenous infusion.

Fludarabine

Administered intravenously

Cyclophosphamide

Administered intravenously

Primary outcome measure

  • Phase 1a: Percentage of Participants Experiencing Treatment-emergent Adverse Event (TEAEs) [ Time Frame: Up to 2 years ]
  • Phase 1a: Percentage of Participants Experiencing Dose-limiting Toxicities (DLTs) After the Infusion of KITE-363 [ Time Frame: Up to 28 days ]
  • Phase 1b: (All Cohorts) Percentage of Participants Experiencing TEAEs [ Time Frame: Up to 2 years ]
  • Phase 1b: Relapsing Forms of MS (RRMS) and (aSPMS): Number of New T1 Gadolinium Enhancing (GadE+) Lesions on Magnetic Resonance Imaging (MRI) at Week 12 [ Time Frame: Week 12 ]
  • Phase 1b: Relapsing Forms of MS (RRMS and aSPMS): Number of New and/or Enlarging T2 Lesions on MRI at Week 12 [ Time Frame: Week 12 ]
  • Phase 1b: Progressive Forms of MS (PPMS) and (naSPMS): Time to Onset of Confirmed Disability Progression Over 12 Weeks (CDP-12) [ Time Frame: Up to 2 years ]
  • Phase 1b: Myasthenia Gravis (MG): Proportion of Participants of MG Activities of Daily Living (MG-ADL) Responders [ Time Frame: Up to Week 24 ]
  • Phase 1b: Chronic Inflammatory Demyelinating Polyneuropathy (CIDP): Proportion of Participants with Confirmed Evidence of Clinical Improvement at Week 24 [ Time Frame: Week 24 ]

Central Contacts and Locations

Central contacts

Locations

Hoag Memorial Hospital Presbyterian

Recruiting

Newport Beach, California, United States, 92663

Stanford Neuroscience Health Center

Recruiting

Palo Alto, California, United States, 94304

Columbia University Irving Medical Center

Recruiting

New York, New York, United States, 10032

LDS Hospital - Intermountain Health

Recruiting

Salt Lake City, Utah, United States, 84143

Fred Hutchinson Cancer Center

Recruiting

Seattle, Washington, United States, 98109

Jewish General Hospital

Recruiting

Montreal, Canada, H3T 1E2

More Information

Sponsor

Kite, A Gilead Company

Last update posted

Aug 14, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Kite, A Gilead Company on 2026-08-14.