Safety and Efficacy of BAFFR CART for Relapsed/ Refractory Neuromyelitis Optica Spectrum Disorder

Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-60
SponsorTianjin Medical University General Hospital

About this trial

This is an open-label, single-arm, dose-escalation study in up to 20 participants with relapsed/refractory Neuromyelitis Optica Spectrum Disorders (NMOSD). The aim is to evaluate the safety and efficacy of the treatment with BAFFR CART.

Eligibility criteria

Qualifiers

Male or female subjects aged 18-60 years;

Patients must be diagnosed as AQP4-IgG-positive NMOSD;

At least one immunosuppressant has been used for over a year with poorly controlled symptoms;

Clinical evidence of at least two relapses in the last 12 months or three relapses in the last 24 months and one relapse in the preceding 12 months before screening.

Disqualifiers

Subjects have received B cell deletion treatment within 6 months before screening;

Chronic and active hepatitis B (HBV), hepatitis C (HCV), Human Immunodeficiency Virus (HIV) infection, CMV or syphilis infections concurrently.

Subjects with Papovaviruses infection.

Subjects have received live attenuated vaccine vaccination within 8 weeks before screening; or plan to receive live vaccine vaccination within 8 weeks after treatment;

Trial design

Treatments tested in this trial

  • Anti-BAFFR CART

Treatment groups

20 Participants
are divided into 1 treatment group

Locations

This trial has no locations