NCT06561009Not yet recruitingPhase 1/2
Safety and Efficacy of BAFFR CART for Relapsed/ Refractory Neuromyelitis Optica Spectrum Disorder
Source: ClinicalTrials.gov · Last updated 16 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 23 Jul 2024
- Start date
- 1 Dec 2026
- Primary completion date
- 1 Oct 2027
- Lead sponsor
- Tianjin Medical University General Hospital
- Diseases
- Neuromyelitis optica (NMOSD)
- NCT number
- NCT06561009
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 20
- From 1 Dec 2026 to the primary completion date, 1 Oct 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Subjects have received B cell deletion treatment within 6 months before screening;
- Subjects have received live attenuated vaccine vaccination within 8 weeks before screening; or plan to receive live vaccine vaccination within 8 weeks after treatment;
Other illness
- Chronic and active hepatitis B (HBV), hepatitis C (HCV), Human Immunodeficiency Virus (HIV) infection, CMV or syphilis infections concurrently.
- Subjects with Papovaviruses infection.
- History of psychoactive drug abuse and failed to withdraw, or have a history of psychiatric disorders.
- 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.
Other
- Pregnant or lactating women.
Who the study is looking for
- 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.
Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.