A Study of HY001N in the Treatment of Relapsed or Refractory Neurological Autoimmune Diseases

Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorJuventas Cell Therapy Ltd.

About this trial

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.

Eligibility criteria

Qualifiers

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;

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • HY001N cell injection

Treatment groups

15 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators

Juventas Cell Therapy Ltd.

Lead sponsor

Beijing Tiantan Hospital

Collaborator