Not yet recruiting NCT06561009
Safety and Efficacy of BAFFR CART for Relapsed/ Refractory Neuromyelitis Optica Spectrum Disorder
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Anti-BAFFR CART.
- Who it may be relevant to
- Registry conditions: Neuromyelitis Optica Spectrum Disorder. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Drug Anti-BAFFR CART
Anti-BAFFR CART
Primary outcome measures
- Incidence of dose-limiting toxicity (DLT) [Time frame: Up to 28 days]
- Incidence and severity of adverse events [Time frame: Up to 28 days]
Secondary outcome measures (8)
- Proportion of BAFFR CART cells in peripheral blood [Time frame: Up to 1 years]
- Annualized relapse rate (ARR) [Time frame: Up to 1 years]
- Changes of B cell levels in bone marrow and peripheral blood [Time frame: Up to 1 years]
- Changes of AQP4 antibody titers [Time frame: Up to 1 years]
- Changes of cytokine in peripheral blood [Time frame: Up to 1 years]
- Changes of Expanded Disability Status Scale (EDSS) score [Time frame: Up to 1 years]
- Changes of visual acuity [Time frame: Up to 1 years]
- Accumulated total active MRI lesions [Time frame: Up to 1 years]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06561009 · IRB2024-YX-220-01