New drug KINE-101 tested for Tough-to-Treat nerve disorder

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Exclusion Criteria: * 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. * 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.