NCT07343310CompletedPhase 1
A First-in-Patient Clinical Trial of KINE-101 in Patients With Corticosteroid-Refractory CIDP
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
Source: ClinicalTrials.gov · Last updated 20 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 9 (actual)
- First submitted
- 10 Dec 2025
- Start date
- 27 Aug 2024
- Primary completion date
- 14 Apr 2025
- Lead sponsor
- Kine Sciences Co., Ltd.
- NCT number
- NCT07343310
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 9
- From 27 Aug 2024 to the primary completion date, 14 Apr 2025
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Known allergy or hypersensitivity to the investigational product or its excipients.
- Use of systemic immunosuppressants or immunostimulants within 5 half-lives prior to IP administration.
- Plasma exchange within 8 weeks prior to IP administration.
- Major surgery within 3 months or planned during study participation.
Other illness
- 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.
- 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.
- 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.
- Chronic infections or expected need for anti-infective treatment during the study.
- Active hepatitis B or C infection or HIV positive.
Lab values
- Abnormal labs at screening: AST/ALT \>3×ULN, Hb \<9 g/dL, ANC \<1,500/μL, Platelets \<100×10³/μL.
Other
- Positive pregnancy test or planning pregnancy, breastfeeding, or gamete donation within 28 days post-IP.
- Investigator deems subject unsuitable for any reason.
Who the study is looking for
- 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
- 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.
Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Kangbuk Samsung Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Samsung Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.