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

Launched by TIANJIN MEDICAL UNIVERSITY GENERAL HOSPITAL · Aug 16, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment called BAFFR CART for patients with a condition known as Neuromyelitis Optica Spectrum Disorder (NMOSD), which can cause severe symptoms and relapses even after other treatments. The goal of the study is to determine how safe and effective this new therapy is. The trial will include up to 20 participants between the ages of 18 and 60 who have been diagnosed with a specific type of NMOSD and have not responded well to previous treatments.

To be eligible, participants must have experienced multiple relapses recently and must be willing to follow certain guidelines, such as using effective birth control. The study will take place in a single group, meaning all participants will receive the same treatment, and they will be closely monitored for their safety and response to the therapy. This trial is not yet recruiting participants, but it represents an important step toward finding better options for people suffering from NMOSD.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Male or female subjects aged 18-60 years;
• • 2. Patients must be diagnosed as AQP4-IgG-positive NMOSD;
• • 3. At least one immunosuppressant has been used for over a year with poorly controlled symptoms;
• • 4. 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.
• • 5. 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.
• • 6. Subjects must provide written informed consent before the study begins and comply with the requirements of the study protocol.
• Exclusion Criteria:
• • 1. Subjects have received B cell deletion treatment within 6 months before screening;
• • 2. Chronic and active hepatitis B (HBV), hepatitis C (HCV), Human Immunodeficiency Virus (HIV) infection, CMV or syphilis infections concurrently.
• • 3. Subjects with Papovaviruses infection.
• • 4. Subjects have received live attenuated vaccine vaccination within 8 weeks before screening; or plan to receive live vaccine vaccination within 8 weeks after treatment;
• • 5. History of psychoactive drug abuse and failed to withdraw, or have a history of psychiatric disorders.
• • 6. Pregnant or lactating women.
• • 7. Subjects with severe heart, liver, kidney or bone marrow function disorder.
• • 8. Allergic constitution or a history of severe allergies.
• • 9. Subjects with conditions adjudicated by the investigator as unsuitable for lymphodepletion or cell infusion.