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RECRUITINGEarly Phase 1INTERVENTIONAL

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

A Clinical Study Evaluating the Safety and Preliminary Efficacy of Universal Allogeneic CAR T-cell Therapy Targeting CD19 and BCMA in Patients With Relapsed / Refractory Neurological Autoimmune Diseases

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

This is an open label, single-site, dose-escalation study in up to 12 participants with relapsed or refractory Neurological Autoimmune Diseases. This study aims to evaluate the safety and efficacy of the treatment with universal CD19/BCMA CAR T-cells.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 conditions (where your immune system attacks your own body)s, 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 willing to sign a consent form form, have good compliance, and cooperate with follow-up. Who Should NOT Join This Trial: - 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 weakened immune system virus (HIV) antibody; individuals positive for syphilis testing. - Pregnant women or women planning to conceive. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DRUG

UCAR T-cell

Universal allogeneic anti-CD19/BCMA CAR T-cells

Locations (1)

Tianjin Huanhu Hospital
Tianjin, China