This study is a single-arm, open-label, non-randomized clinical trial aimed at evaluating the safety, tolerability and preliminary efficacy of HY001N cell injection in the treatment of patients with relapsed/refractory Neurological Autoimmune Diseases.
Patients who are willing to sign the informed consent form;
Aged 18-75 years, male or female;
aquaporin 4 (AQP4) -IgG positive
At least one immunosuppressant has been used for more than one year and the symptoms have not been well controlled;
Current medical conditions or neurological disorders that may affect the effectiveness assessment, such as dementia, schizophrenia, bipolar disorder, major depressive disorder, history of multiple traumatic brain injury, current alcohol/drug abuse or dependence, or alcohol/drug dependence within the past two years.
Pregnancy or breastfeeding;
Have received organ or hematopoietic stem cell transplantation in the past;
There has been a history of new thrombosis or organ infarction within the past six months;
Single group
HY001N cell injection
Biological/VaccineA conditioning chemotherapy regimen of fludarabine and cyclophosphamide will be administered followed by investigational treatment, HY001N.
Number of participants with dose-limiting toxicities (DLTs)
Number of participants with adverse events (AEs)/serious adverse events (SAEs)
AEs and SAEs: The frequency, severity, and laboratory findings of all adverse events/serious adverse events are included.
Number of participants with disability improvement confirmed per EDSS
NMOSD、MOGAD
Annualized relapse rate
NMOSD、MOGAD、MS
Change from baseline in magnetic resonance imaging (MRI) metrics
NMOSD、MOGAD：MRI metrics assessed are 1) number of gadolinium-enhancing T1 lesions and 2) total number of new or enlarging hyperintense T2-weigted lesions
Number of participants with confirmed disability progression per Expanded Disability Status Scale (EDSS)
MS
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Juventas Cell Therapy Ltd.
Lead sponsor
Beijing Tiantan Hospital
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
