Status:
NOT_YET_RECRUITING
Safety and Efficacy of BAFFR CART for Relapsed/ Refractory Neuromyelitis Optica Spectrum Disorder
Lead Sponsor:
Tianjin Medical University General Hospital
Conditions:
Neuromyelitis Optica Spectrum Disorder
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
PHASE2
Brief Summary
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 effica...
Eligibility Criteria
Inclusion
- 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.
- Subjects and their partners must be willing to use effective and reliable methods of contraception, devices or medicines, within one year before BAFFR CART cells infusion.
- Subjects must provide written informed consent before the study begins and comply with the requirements of the study protocol.
Exclusion
- 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;
- History of psychoactive drug abuse and failed to withdraw, or have a history of psychiatric disorders.
- Pregnant or lactating women.
- Subjects with severe heart, liver, kidney or bone marrow function disorder.
- Allergic constitution or a history of severe allergies.
- Subjects with conditions adjudicated by the investigator as unsuitable for lymphodepletion or cell infusion.
Key Trial Info
Start Date :
December 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2028
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06561009
Start Date
December 1 2025
End Date
October 1 2028
Last Update
May 30 2025
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