Chronic Inflammatory Demyelinating PolyneuropathyPhase 1HERMOSA-2NCT07304154
Study of KITE-363 in Participants With Autoimmune Neurologic Diseases That Did Not Respond to Usual Treatment
A Phase 1 study testing KITE-363, Fludarabine and Cyclophosphamide in people with Chronic Inflammatory Demyelinating Polyneuropathy and Myasthenia Gravis, run by Kite, A Gilead Company at 10 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Inflammatory Demyelinating Polyneuropathy, Myasthenia Gravis, Multiple Sclerosis
- What is being tested?
- KITE-363, Fludarabine and Cyclophosphamide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 10 sitesin 3 countries
- Study dates
- 10 Apr 2026to Jun 2029
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- 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)):
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- 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
- 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
Who cannot join
- 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)
- 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)
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- Any contraindication to lumbar puncture (LP) (for the relapsing forms of MS and progressive forms of MS)
- Current myasthenic crisis not effectively controlled within 2 weeks before enrollment
- Thymectomy performed within 12 months of baseline
- Pure sensory CIDP and focal CIDP
- Polyneuropathy of other causes
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
10 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
10 sites in 3 countries
United States5 sites, 5 recruiting
- Recruiting
Columbia University Irving Medical Center
New York, New York, 10032
- Recruiting
Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92663
- Recruiting
Stanford Neuroscience Health Center
Palo Alto, California, 94304
- Recruiting
LDS Hospital - Intermountain Health
Salt Lake City, Utah, 84143
- Recruiting
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
Canada3 sites, 3 recruiting
- Recruiting
Centre Intégré Universitaire de Sante et Services Sociaux de L'Est de I'lle de Montreal / installation Hopital Maisonneuve-Rosemont
Montreal, H1T 2M4
- Recruiting
Jewish General Hospital
Montreal, H3T 1E2
- Recruiting
The Ottawa Hospital - General Campus
Ottawa, K1H 8L6
Australia2 sites, 2 recruiting
- Recruiting
Concord Repatriation General Hospital
Sydney, New South Wales, 2139
- Recruiting
Corner Hawkesbury Road and Darcy Road
Westmead, New South Wales, 2145
About this study
Official title: 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
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
- Being tested
- KITE-363, Fludarabine, Cyclophosphamide
- Medical subject headings
- Polyradiculoneuropathy, Chronic Inflammatory Demyelinating, Myasthenia Gravis, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KITE-363Biological
A single infusion of CAR-transduced autologous T cells administered as intravenous infusion.
FludarabineDrug
Administered intravenously
CyclophosphamideDrug
Administered intravenously
| Study group | Role | What they receive |
|---|---|---|
| Phase 1a: KITE-363 (Dose Escalation) With Lymphodepleting Chemotherapy | Experimental | 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. Receives: Biological: KITE-363; Drug: Fludarabine; Drug: Cyclophosphamide |
| Phase 1a: KITE-363 (Dose Escalation) Without Lymphodepleting Chemotherapy | Experimental | Participants with RMS, PMS, MG, and/or CIDP will receive infusion of KITE-363 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. Receives: Biological: KITE-363 |
| Phase 1b: KITE-363 (Dose Expansion) | Experimental | 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. Receives: Biological: KITE-363; Drug: Fludarabine; Drug: Cyclophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1a: Percentage of Participants Experiencing Treatment-emergent Adverse Event (TEAEs)
Measured: Up to 3 years
Phase 1a: Percentage of Participants Experiencing Dose-limiting Toxicities (DLTs) After the Infusion of KITE-363
Measured: Up to 28 days
Phase 1b: (All Cohorts) Percentage of Participants Experiencing TEAEs
Measured: Up to 3 years
Phase 1b: Relapsing Forms of MS (RRMS) and Active Secondary-progressive Multiple Sclerosis (aSPMS): Number of New T1 Gadolinium Enhancing (GadE+) Lesions on Magnetic Resonance Imaging (MRI) at Week 12
This will be reported in participants with relapsing forms of Multiple Sclerosis MS (RRMS) and (aSPMS).
Measured: Week 12
Phase 1b: Relapsing Forms of MS (RRMS and aSPMS): Number of New and/or Enlarging T2 Lesions on MRI at Week 12
Measured: Week 12
Phase 1b: Progressive Forms of MS (PPMS) and Non-active Secondary-progressive Multiple Sclerosis (naSPMS): Time to Onset of Confirmed Disability Progression Over 12 Weeks (CDP-12)
Measured: Up to 3 years
Phase 1b: Myasthenia Gravis (MG): Proportion of Participants of MG Activities of Daily Living (MG-ADL) Responders
The MG-ADL is a scale to measure the functional impact of MG on daily activities. The total score ranges from 0 to 24, with higher scores indicating greater disability and disease burden.
Measured: Up to 3 years
Phase 1b: CIDP: Proportion of Participants with a ≥ 2 Points Improvement from Baseline in aINCAT Score at Week 24, in the Absence of CIDP Rescue Therapy or Initiation of New Maintenance Immunomodulatory Therapy
Clinical improvement will be analyzed using adjusted inflammatory neuropathy cause and treatment (aINCAT) scale. The INCAT score is a clinician administered tool used to assess functional disability in participants with chronic inflammatory demyelinating polyneuropathy (CIDP). The total scores range from 0 to 10, higher scores indicating greater disability and lower score would indicate clinical improvement.
Measured: Up to 3 years
Secondary outcomes (48)
Relapsing forms of MS (RRMS and aSPMS): Annual Relapse Rate
Proportion of participants with annual relapse.
Measured: Up to 3 years
Relapsing Forms of MS (RRMS and aSPMS): Proportion of Participants With CDP-12
Measured: Up to 3 years
Relapsing Forms of MS (RRMS and aSPMS): Proportion of Participants With CDP-24
Measured: Up to 3 years
Relapsing Forms of MS (RRMS and aSPMS): Time to Onset of CDP-12
Measured: Up to 3 years
Relapsing Forms of MS (RRMS and aSPMS): Time to Onset of CDP-24
Measured: Up to 3 years
Progressive forms of MS (PPMS and naSPMS): Proportion of Participants with No Evidence of Disease Activity (NEDA)
Measured: Up to 3 years
Relapsing Forms of MS (RRMS and aSPMS): Change From Baseline in Expanded Disability Status Scale (EDSS) Score Over Time
EDSS is scale used to measure disability and disease progression in participants with MS. It ranges from 0 (normal neurological exam) to 10 (death due to MS) in 0.5-point increments.
Measured: Up to 3 years
Relapsing Forms of MS (RRMS and aSPMS): Change From Baseline in Timed 25-foot Walk (T25FW) Score Over Time
The T25FW is a performance-based measure used in people with MS to assess walking speed and mobility. Lower times indicate better walking ability, while longer times reflect greater impairment.
Measured: Up to 3 years
Relapsing Forms of MS (RRMS and aSPMS): Change From Baseline in 9-hole Peg Test Dominant/Non-dominant (9-HPT D/ND) Score Over Time
The 9-HPT assesses hand dexterity and fine motor function by timing how long it takes a participant to place and remove nine pegs from a board. Faster times indicate better function, while slower times reflect greater disability.
Measured: Up to 3 years
Relapsing Forms of MS (RRMS and aSPMS): Change From Baseline in Symbol Digit Modalities Test (SDMT) Score Over Time
SDMT is a performance-based cognitive assessment to measure information processing speed. The score is the number of correct responses completed in the time limit, with higher scores indicating better cognitive processing speed.
Measured: Up to 3 years
Progressive Forms of MS (PPMS and naSPMS): Proportion of Participants with CDP-12
Measured: Up to 3 years
Progressive Forms of MS (PPMS and naSPMS): Proportion of Participants with CDP-24
Measured: Up to 3 years
Progressive forms of MS (PPMS and naSPMS): Time to Onset of CDP-24
Measured: Up to 3 years
Progressive forms of MS (PPMS and naSPMS): Number of new and Enlarging T2 Lesions on MRI
Measured: Up to 3 years
Relapsing forms of MS (RRMS and aSPMS): Percentage of Participants With NEDA
Measured: Up to 3 years
Progressive forms of MS (PPMS and naSPMS): Change From Baseline in EDSS Over Time
EDSS is scale used to measure disability and disease progression in participants with MS. It ranges from 0 (normal neurological exam) to 10 (death due to MS) in 0.5-point increments.
Measured: Up to 3 years
Progressive forms of MS (PPMS and naSPMS): Change From Baseline in T25FW Over Time
The T25FW is a performance-based measure used in people with MS to assess walking speed and mobility. Lower times indicate better walking ability, while longer times reflect greater impairment.
Measured: Up to 3 years
Progressive forms of MS (PPMS and naSPMS): Change From Baseline in 9-HPT D/ND Over Time
The 9-HPT assesses hand dexterity and fine motor function by timing how long it takes a participant to place and remove nine pegs from a board. Faster times indicate better function, while slower times reflect greater disability.
Measured: Up to 2 years
Progressive forms of MS (PPMS and naSPMS): Change From Baseline in SDMT Over Time
SDMT is a performance-based cognitive assessment to measure information processing speed. The score is the number of correct responses completed in the time limit, with higher scores indicating better cognitive processing speed.
Measured: Up to 3 years
MG: Proportion of Participants With at Least a 2-Point or 5 Point Improvement in MG-ADL Score up to Week 24
The MG-ADL is a scale to measure the functional impact of MG on daily activities. The total score ranges from 0 to 24, with higher scores indicating greater disability and disease burden.
Measured: Up to 24 weeks
MG: Change From Baseline in MG-ADL Score at Week 24
The MG-ADL is a scale to measure the functional impact of MG on daily activities. The total score ranges from 0 to 24, with higher scores indicating greater disability and disease burden.
Measured: Baseline, Week 24
MG: Proportion of Participants With Minimal Symptom Expression (MG-ADL Score of 0 or 1 Point)
The MG-ADL is a scale to measure the functional impact of MG on daily activities. The total score ranges from 0 to 24, with higher scores indicating greater disability and disease burden.
Measured: Up to 3 years
MG: Proportion of Participants With at Least a 3-point or 5-point Improvement in Medical Research Council (QMG) Score up to Week 24
The QMG test is a standardized quantitative strength scoring system developed specifically for MG. The total QMG score is the sum of the scores for 13 items, with a possible maximum score of 39. A higher score indicates more severe disease involvement, while a lower score suggests less functional impairment.
Measured: Baseline, Week 24
MG: Change From Baseline in QMG Score to Week 24
The QMG test is a standardized quantitative strength scoring system developed specifically for MG. The total QMG score is the sum of the scores for 13 items, with a possible maximum score of 39. A higher score indicates more severe disease involvement, while a lower score suggests less functional impairment.
Measured: Baseline, Week 24
MG: Proportion of Participants With at Least a 3-Point Improvement in MG-C Score up to Week 24
MG-C scale is a tool that measures disease severity in MG. The total score ranges from 0 to 50, with higher scores indicating greater impairment.
Measured: Baseline, Up to 24 weeks
Change From Baseline in MG-C Scale Score at Week 24
MG-C scale is a tool that measures disease severity in MG. The total score ranges from 0 to 50, with higher scores indicating greater impairment.
Measured: Baseline, Week 24
MG: Number of Participants With Changes in Myasthenia Gravis Foundation of American Post-Intervention Status (MGFA-PIS), Including Minimal Manifestation, Complete Stable Remission, Pharmacologic Remission
The MGFA-PIS is a standardized classification system which categorizes outcomes into distinct states such as complete stable remission (CSR), pharmacologic remission (PR), minimal manifestations (MM), improved, unchanged, worse, and exacerbation. CSR indicates no symptoms or signs for at least one year without therapy, while MM reflects minimal weakness without functional limitation.
Measured: Up to 3 years
CIDP: Proportion of Participants With a ≥ 1-point Improvement from Baseline in aINCAT Score at Week 24, in the Absence of CIDP Rescue Therapy or Initiation of New Maintenance Immunomodulatory Therapy
Clinical improvement will be analyzed using INCAT scale. The INCAT score is a clinician administered tool used to assess functional disability in participants with CIDP. The total scores range from 0 to 10, higher scores indicating greater disability and lower score would indicate improvement.
Measured: Week 24
Proportion of Participants With a ≥ 2-point Improvement from Baseline in aINCAT Score at Week 24
Clinical improvement will be analyzed using INCAT scale. The INCAT score is a clinician administered tool used to assess functional disability in participants with CIDP. The total scores range from 0 to 10, higher scores indicating greater disability and lower score would indicate improvement.
Measured: Week 24
Proportion of Participants Without aINCAT Deterioration and Without Requirement for CIDP Rescue or Maintenance Therapy Through Week 24
Measured: Up to Week 24
Proportion of Participants With ≥ 1-point Improvement in INCAT Lower Limb Score from Baseline to Week 24, in the Absence of CIDP Rescue Therapy or Initiation of New Maintenance Immunomodulatory Therapy
Clinical improvement will be analyzed using INCAT scale. The INCAT score is a clinician administered tool used to assess functional disability in participants with CIDP. The total scores range from 0 to 10, higher scores indicating greater disability and lower score would indicate improvement.
Measured: Baseline, up to Week 24
Proportion of Participants Transitioning from INCAT Lower Limb score ≥ 3 (Assistive Device) to ≤ 2 (Independent Ambulation) from Baseline to Week 24, in the Absence of CIDP Rescue Therapy or Initiation of New Maintenance Immunomodulatory Therapy
The INCAT score is a clinician administered tool used to assess functional disability in participants with CIDP. The total scores range from 0 to 10, higher scores indicating greater disability and lower score would indicate improvement.
Measured: Baseline, up to Week 24
CIDP: Time to First aINCAT Deterioration
INCAT is a clinician-administered tool used to assess functional disability in participants with CIDP. The total score ranges from 0 to 10, where higher scores indicate greater disability and lower score would indicate clinical improvement.
Measured: Up to 3 years
CIDP: Proportion of Participants With Evidence of Clinical Improvement
Clinical improvement will be analyzed using inflammatory Rasch-built overall disability scale (I-RODS) scale. I-RODS is a scale that assesses activity and participation limitations in people with CIDP. The score ranges from 0 to 48, with higher scores indicating better functional ability.
Measured: Up to week 24
CIDP: Change From Baseline Over Time in Adjusted INCAT Score
INCAT is a tool used to assess functional disability in participants with CIDP. The total score ranges from 0 to 10, where higher scores indicate greater disability.
Measured: Up to 3 years
CIDP: Change From Baseline Over Time in 24-Item I-RODS Score
I-RODS is a scale that assesses activity and participation limitations in people with CIDP. The score ranges from 0 to 48, with higher scores indicating better functional ability.
Measured: Up to 3 years
CIDP: Change From Baseline Over Time in Medical Research Council (MRC) Sum Score
MRC Sum Score is a measure to assess muscle strength for people with CIDP. The score ranges from 0 to 60. Higher scores indicate better muscle strength, while lower scores reflect greater weakness.
Measured: Up to 3 years
CIDP: Change From Baseline Over Time in Timed Up and Go (TUG) Score
TUG test is a measure of mobility, balance, and fall risk. The score is recorded in seconds; shorter times indicate better mobility, while longer times suggest impaired balance or gait.
Measured: Up to 3 years
CIDP: Change From Baseline Over Time in Mean Grip Strength
Mean Grip Strength is a quantitative measure of hand and forearm muscle strength. Higher values indicate better muscle strength, while lower values reflect weakness or functional impairment.
Measured: Up to 3 years
Proportion of Participants With European Quality of Life 5-Dimension 5-Level Questionnaire (EQ-5D-5L)
The EQ-5D-5L is a generic measure of health status captured on the day of assessment. Two components comprise the EQ-5D-5L: the EQ-5D descriptive system and the EQ visual analog scale (VAS). The descriptive system comprises 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and is divided into 5 levels of severity: "no problems," "slight problems," "moderate problems," "severe problems," and "extreme problems." The EQ-5D-5L VAS is a vertical VAS for recording self-rated current HRQoL, and it ranges from 0, described as "the worst health you can imagine," to 100, described as "the best health you can imagine." EQ-5D-5L will be scored according to the published administration and scoring manual.
Measured: Up to 3 years
Proportion of Participants With Chronic Acquired Polyneuropathy Patient-reported Index (CAP-PRI)
The CAP-PRI is a tool developed to assess the impact of chronic acquired polyneuropathy on participant's quality of life, capturing both physical and psychological symptoms from the participant's perspective. The scoring of the CAP-PRI is typically based on how participants rate their symptoms and overall health across various dimensions, such as sensory symptoms, motor function, pain, emotional well-being, and fatigue. Each dimension of the CAP-PRI is scored separately, and the results are summed up to give an overall score for the participant, with higher scores indicating greater severity or a worse quality of life. Each domain typically uses a Likert scale or similar ordinal scale, where participants rate their experience or symptoms on a scale from 0 to 5.
Measured: Up to 3 years
Proportion of Participants With Rasch-Transformed Fatigue Severity Scale (RT-FSS)
The RT-FSS or FSS-7 is a refined version of the original 9-item Fatigue Severity Scale (FSS-9) designed to improve accuracy in measuring fatigue, particularly in participants with immune-mediated neuropathies. The original 7-point Likert scale was collapsed into a 4-point response category for the remaining items to fulfill strict linearity requirements. It is a linearly weighted scale, meaning its scores provide a more precise, interval-level measurement rather than just an ordinal ranking. It was specifically validated for conditions like Guillain-Barré syndrome and CIDP. This modified scale provides a more stable test-retest reliability. The scale is used to distinguish between different levels of fatigue impact on daily activities, though it may have a ceiling effect for patients with extremely severe symptoms.
Measured: Up to 3 years
Levels of T-cells in Blood
Measured: Up to 2 years
Pharmacokinetics: Levels of Chimeric Antigen Receptor (CAR) T-cells in Blood
Measured: Up to 2 years
Pharmacodynamics Parameters: Levels of B cells in Blood
Measured: Up to 2 years
Pharmacodynamics Parameters: Levels of Disease-Specific Biomarkers and Autoantibodies in Blood
Measured: Up to 2 years
Pharmacodynamics Parameters: Levels of Cytokines and Chemokines in Blood
A panel of inflammatory, immuno-modulatory and effector molecules, including cytokines and chemokines, will be measured as units of concentration in serum (e.g. pg/ml) using ligand-based immunoassays such as MSD, Ella and O-link.
Measured: Up to 2 years
Proportion of Participants With of Antibodies Against the KITE-363 CAR T cells in Blood
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2025
- Study start10 Apr 2026
- Primary completionJun 2029 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Inflammatory Demyelinating PolyneuropathyStudies of the same condition, open and under way.
- More trials run by Kite, A Gilead CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 57 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kite, A Gilead Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kite Study Director, Study director, Kite, A Gilead Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07304154
- Sponsor's protocol ID
- KT-US-728-0204
- Acronym
- HERMOSA-2
- Status last verified
- Oct 2026
- First submitted
- 12 Dec 2025
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No