A Phase I Clinical Trial of UX-GIP001 in the Treatment of Drug-Resistant Unilateral Mesial Temporal Lobe Epilepsy

Korábbi kezelés

• History of status epilepticus within 12 months prior to screening.
• Presence of long-term implants in the skull or intracranial space.
• History of clear suicidal intent, plan, or behavior within one year prior to screening.

Más betegség

• Epilepsy caused by other/or progressive neurological diseases , or patients - experiencing only focal aware seizures without observable manifestations.
• History of epilepsy surgery.
• Severe systemic disease or dysfunction.
• Severe psychiatric disorders.

Életkor

• History of malignancy within the past 5 years, except for cervical carcinoma in situ, basal cell or squamous cell skin cancer cured for >5 years.

Egyéb

• Primary or secondary immunodeficiency.
• Pregnant or breastfeeding women.

• Age 18-75 years (inclusive), male or female;
• Diagnosis of focal epilepsy according to the International League Against Epilepsy (ILAE) 2025 epilepsy classification, with disease duration ≥2 years;
• Clinical presentation consistent with unilateral mesial temporal lobe epilepsy (MTLE);
• Meeting the diagnostic criteria for drug-resistant epilepsy;
• Average focal seizure frequency ≥4 per 28 days within the 3 months prior to screening;
• On a stable dose of anti-seizure medications for ≥1 month prior to enrollment;
• Patient has adequate organ function as follows: absolute neutrophil count ≥2.0×10⁹/L; white blood cell count ≥4.0×10⁹/L; platelet count ≥100×10⁹/L; AST and ALT ≤2.5× upper limit of normal (ULN); total bilirubin ≤1.5× ULN; serum creatinine ≤1.5× ULN; estimated glomerular filtration rate (eGFR) ≥60 mL/min/1.73 m² (calculated using the CKD-EPI formula);
• Women of childbearing potential must have a negative serum pregnancy test during the screening period. All participants and their partners agree to have no plans for pregnancy, sperm donation, or egg donation from the time of signing the informed consent form until 2 years after cell transplantation treatment, and voluntarily adopt contraceptive measures deemed effective by the investigator;
• Patient has good compliance, with a patient diary completion rate ≥80% prior to enrollment.