CIDP - Chronic Inflammatory Demyelinating PolyneuropathyPhase 1NCT07343310

A First-in-Patient Clinical Trial of KINE-101 in Patients With Corticosteroid-Refractory CIDP

A Phase 1 study testing KINE-101 in people with CIDP - Chronic Inflammatory Demyelinating Polyneuropathy, run by Kine Sciences Co., Ltd. at 2 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 19 years and older
Conditions the study is for: CIDP - Chronic Inflammatory Demyelinating Polyneuropathy
What is being tested?: KINE-101
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 9 participants
Where: 2 sitesSouth Korea
Study dates: 27 Aug 2024to 14 Apr 2025
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 19 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Adults aged ≥19 years at informed consent.
Diagnosed with CIDP and refractory to corticosteroid treatment for ≥3 months prior to enrollment, or corticosteroid treatment deemed inappropriate or cannot be continued for safety reasons.
Meets EAN/PNS 2021 criteria for typical CIDP:
Progressive or relapsing symmetrical motor weakness in arms and legs with sensory involvement in ≥2 limbs
Symptom duration ≥8 weeks
Reduced or absent tendon reflexes in all extremities

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INCAT disability score ≥2 at screening (score of 2 must result solely from leg disability).
CIDP Disease Activity Status (CDAS) score ≥3 at screening.
Received IVIg ≥2 months prior to IP administration.
If the subject is of childbearing potential, agrees to use highly effective contraception for ≥28 days after IP administration.
Adequate venous access for IV administration and blood sampling.
Willing and able to comply with all study procedures.

Who cannot join

Polyneuropathy due to other causes (e.g., MMN, MGUS with anti-MAG antibodies, hereditary neuropathies, POEMS syndrome, diabetic or systemic disease-related neuropathy, drug/toxin-induced neuropathy).
History of myelopathy or confirmed central demyelination.
Known allergy or hypersensitivity to the investigational product or its excipients.
Uncontrolled severe hepatic disease, CNS disorders, alcoholism, substance abuse, or psychiatric disorders.
Other medical conditions that better explain symptoms (e.g., stroke, CNS trauma, connective tissue disease).
Malignancy within 5 years, except adequately treated low-risk cancers.

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Moderate to severe heart failure or severe cardiovascular disease (e.g., MI, ischemic stroke).
Moderate to severe substance or alcohol use disorder within 1 year.
Positive pregnancy test or planning pregnancy, breastfeeding, or gamete donation within 28 days post-IP.
Use of systemic immunosuppressants or immunostimulants within 5 half-lives prior to IP administration.
Plasma exchange within 8 weeks prior to IP administration.
Chronic infections or expected need for anti-infective treatment during the study.
Active hepatitis B or C infection or HIV positive.
Abnormal labs at screening: AST/ALT >3×ULN, Hb <9 g/dL, ANC <1,500/μL, Platelets <100×10³/μL.
Major surgery within 3 months or planned during study participation.
Investigator deems subject unsuitable for any reason.

Trial locations and contacts

2 sites in 1 country.

South Korea2 sites

Kangbuk Samsung Hospital
Seoul, Seoul, 03181
Samsung Medical Center
Seoul, Seoul, 06351

Other trials in South Korea

About this study

Official title: Multi-Center, Open-label, Single Dosing, Dose-Ascending, Phase 1 Study to Evaluate the Safety and Tolerability of KINE-101 in Patients With CIDP (Chronic Inflammatory Demyelinating Polyneuropathy) Refractory to Corticosteroid Treatment

This is a multicenter, open-label, single-dose, dose-escalation study evaluating the safety and tolerability of intravenous (IV) KINE-101 in patients with corticosteroid-refractory chronic inflammatory demyelinating polyneuropathy (CIDP). On Day 1, subjects receive a single IV dose of KINE-101 at the assigned cohort level and are discharged on Day 3, approximately 48 hours after investigational product (IP) administration, once all required in-clinic assessments have been completed. Safety assessments (including dose-limiting toxicities [DLTs], adverse events, clinical laboratory tests, vital signs, physical examinations, and 12-lead ECGs), exploratory efficacy evaluations, and PK/PD assessments are conducted through Day 28 in accordance with the schedule of assessments.

Exploratory efficacy assessments through Day 28 include changes from baseline in the following clinical measures: Inflammatory Neuropathy Cause and Treatment (INCAT) disability score, Medical Research Council (MRC) total sum score, Inflammatory Rasch-Built Overall Disability Scale (I-RODS), Timed Up-and-Go (TUG) test, mean grip strength, and the Overall Neuropathy Limitations Scale (ONLS).

Pharmacodynamic (PD) assessments include immunophenotyping of CD4+ T-cell subsets (CD4, CD25, FOXP3, CD39, CD69, CTLA-4, LAG-3, TNFR2, TIGIT, CCR5, and CXCR3); measurement of serum cytokines and immunoglobulins (IgM, IgG, IL-2, IL-6, IL-10, IL-17, IFN-γ, MCP-1, and TGF-β); evaluation of autoantibody and complement markers (antinuclear antibodies, anti-SM, anti-RNP, anti-SSA, anti-double-stranded DNA antibodies, and complement C4); and additional laboratory parameters related to systemic inflammation.

Dose escalation follows a standard 3+3 design based on review of safety, including DLTs, in the preceding cohort. Three KINE-101 dose cohorts are planned: Cohort 1 (120 mg), Cohort 2 (240 mg), and Cohort 3 (360 mg). If safety and tolerability are deemed acceptable in a given cohort, enrollment proceeds sequentially to the next higher dose level.

Conditions: CIDP - Chronic Inflammatory Demyelinating Polyneuropathy
Being tested: KINE-101
Medical subject headings: Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

KINE-101Drug
KINE-101 injection, 12.5 mg/mL, administered once intravenously on Day 1.

Study groups in NCT07343310
Study group	Role	What they receive
KINE-101 120mg	Experimental	Subjects received a single intravenous dose of KINE-101 120 mg. Receives: Drug: KINE-101
KINE-101 240 mg	Experimental	Subjects received a single intravenous dose of KINE-101 240 mg. Receives: Drug: KINE-101
KINE-101 360 mg	Experimental	Subjects received a single intravenous dose of KINE-101 360 mg. Receives: Drug: KINE-101

What is being measured

The primary outcome is the main question the study is designed to answer.

Incidence of Adverse Events (AEs)
Incidence, severity, and relationship of treatment-emergent adverse events following a single intravenous dose of KINE-101.
Measured: Day 1 to Day 28
Number of Participants with Clinically Significant Abnormal Hematology
Count of participants with clinically significant abnormal hematology findings (e.g., white blood cell count, hemoglobin, platelets, absolute neutrophil count), as defined per protocol.
Measured: Day 1 to Day 28
Number of Participants with Clinically Significant Abnormal Clinical Chemistry
Count of participants with clinically significant abnormal clinical chemistry findings (e.g., ALT, AST, creatinine), as defined per protocol.
Measured: Day 1 to Day 28
Number of Participants with Clinically Significant Abnormal Urinalysis
Count of participants with clinically significant abnormal urinalysis findings (e.g., protein/albumin, glucose, pH), as defined per protocol.
Measured: Day 1 to Day 28
Number of Participants with Clinically Significant Abnormal Vital Signs
Count of participants with clinically significant abnormal vital sign findings (e.g., systolic or diastolic blood pressure, pulse rate, body temperature, respiratory rate), as defined per protocol.
Measured: Day 1 to Day 28
Number of Participants with Clinically Significant Abnormal Physical Examination
Count of participants with clinically significant abnormal physical examination findings, as defined per protocol.
Measured: Day 1 to Day 28
Number of Participants with Clinically Significant Abnormal Electrocardiogram
Count of participants with clinically significant abnormal electrocardiogram findings (e.g., PR interval, QRS duration, QT interval), as defined per protocol.
Measured: Day 1 to Day 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Aug 202414 Apr 2025

First posted15 Jan 2026
Study start27 Aug 2024
Primary completion14 Apr 2025
Study completion14 Apr 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for CIDP - Chronic Inflammatory Demyelinating PolyneuropathyStudies of the same condition, open and under way.
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
Model description: Sequential dose escalation in single experimental arm with cohorts receiving 120 mg, 240 mg, or 360 mg.
Masking: None (open label)
Enrolment: 9 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07343310
Sponsor's protocol ID: CIDP101-CR1-001P
Status last verified: Jan 2026
First submitted: 10 Dec 2025
Last updated: 20 Jan 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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