The Safety and Efficacy of Universal CAR-T Cells Targeting BCMA in the Treatment of Refractory NMOSD

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorBioray Laboratories

About this trial

This is an open label, Multi-center,dose-escalation study in up to 18 participants with refractory NMOSD. This study aims to evaluate the safety and efficacy of universal CAR-T Cells targeting BCMA in the Treatment of refractory NMOSD.

Eligibility criteria

Qualifiers

Aged 18-65 years ; both genders eligible.

Meets the criteria for Refractory NMOSD.

Anticipated survival of ≥ 12 weeks as judged by the researcher.

Agrees to use double barrier methods, condoms, oral or injectable contraceptives, or intrauterine devices during the study period and for one year after taking the study medication.

Disqualifiers

History of solid organ transplantation.

Malignant tumor within the last two years.

Positive for Hepatitis B surface antigen (HBsAg) or Hepatitis B core antibody (HBcAb), with peripheral blood Hepatitis B virus (HBV) DNA detected as positive; positive for Hepatitis C virus antibodies, with peripheral blood Hepatitis C virus RNA detected as positive; positive for Human Immunodeficiency Virus (HIV) antibodies; positive for Cytomegalovirus (CMV) DNA; positive for syphilis.

Primary immunodeficiency (congenital or acquired).

Trial design

Treatments tested in this trial

  • Universal BCMA-CD19 CART

Treatment groups

18 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators

Bioray Laboratories

Lead sponsor

Wenzhou Medical University Affiliated Ophthalmology Hospital

Collaborator