NCT07343310Befejeződött1. fázis
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
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. jan. 20.
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Befejeződött
- Fázis (regiszter)
- 1. fázis
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 9 (tényleges)
- Első benyújtás
- 2025. dec. 10.
- Kezdés
- 2024. aug. 27.
- Elsődleges befejezés
- 2025. ápr. 14.
- Fő szponzor
- Kine Sciences Co., Ltd.
- NCT-szám
- NCT07343310
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó · 1. fázis
- Bevont résztvevők: 9
- 2024. aug. 27. és az elsődleges befejezés (2025. ápr. 14.) között
- 2 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
Ki nem vehet részt
Szó szerint a(z) ClinicalTrials.gov forrásból, témák szerint csoportosítva. Hogy ki vehet részt, azt csak a vizsgálat csapata dönti el.
Korábbi kezelés
- 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.
Más betegség
- 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.
Laborértékek
- Abnormal labs at screening: AST/ALT >3×ULN, Hb <9 g/dL, ANC <1,500/μL, Platelets <100×10³/μL.
Egyéb
- Positive pregnancy test or planning pregnancy, breastfeeding, or gamete donation within 28 days post-IP.
- Investigator deems subject unsuitable for any reason.
Kiket keres a vizsgálat
- 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.
Életkor a regiszterben: 19 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (2)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Kangbuk Samsung Hospital | Seoul | Dél-Korea | Ismeretlen állapot |
| Samsung Medical Center | Seoul | Dél-Korea | Ismeretlen állapot |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.