Universal Chimeric Antigen Receptor T-Cell （UCAR T-cell） Therapy Targeting CD19/B Cell Maturation Antigen （CD19/BCMA） in Patients With r/r Neurological Autoimmune Diseases

Launched by TIANJIN HUANHU HOSPITAL · Apr 14, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called Universal Chimeric Antigen Receptor T-Cell (UCAR T-cell) therapy, specifically aimed at helping patients with certain neurological autoimmune diseases. These conditions include neuromyelitis optica spectrum disorders, myasthenia gravis, multiple sclerosis, chronic inflammatory demyelinating polyradiculoneuropathy, and autoimmune encephalitis. The trial will evaluate how safe and effective this treatment is for patients who have not responded well to other therapies.

To participate, individuals must be at least 18 years old and have specific types of B cells present in their blood. They should also be diagnosed with one of the targeted neurological autoimmune diseases. Participants will need to follow certain health guidelines and agree to regular follow-ups during the study. It’s important to note that the trial is not yet recruiting participants, and those with certain health issues, like severe allergies or recent cancers, will not be eligible. Overall, this trial offers a potential new avenue for patients seeking relief from difficult-to-treat neurological conditions.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age ≥ 18 years.
• • Flow cytometry detected positive B cell CD19 or BCMA in the patient's peripheral blood.
• • Subjects with relapsed or refractory neurological autoimmune diseases, Including neuromyelitis optica spectrum disorders(NMOSD), myasthenia gravis(MG), multiple sclerosis(MS)，Autoimmune encephalitis(AE) and chronic inflammatory demyelinating Polyradiculoneuropathy(CIDP).
• • Female subjects of childbearing potential and male subjects with partners of childbearing potential must use medically approved contraception or abstinence during the study treatment period and for at least 6 months after the end of the study treatment; Female subjects of childbearing potential must have a negative Human chorionic gonadotropin (HCG) test within 7 days before study enrollment and not be lactating.
• • Willing to participate in this clinical study, sign an informed consent form, have good compliance, and cooperate with follow-up.
• Exclusion Criteria:
• • Subjects with a history of severe drug allergies or allergic tendencies.
• • History of malignancy within five years.
• • Subjects with insufficient cardiac function.
• • Subjects who are positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with peripheral blood HBV DNA \>the upper limit of detection; subjects positive for hepatitis C virus (HCV) antibody and peripheral blood HCV RNA; individuals positive for human immunodeficiency virus (HIV) antibody; individuals positive for syphilis testing.
• • Pregnant women or women planning to conceive.