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RecruitingEarly Phase 1NCT06939166

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

Sponsor

Tianjin Huanhu Hospital

Enrollment

12 participants

Start Date

Jun 17, 2025

Study Type

INTERVENTIONAL

Conditions

Myasthenia GravisAutoimmune EncephalitisMultiple SclerosisChronic Inflammatory Demyelinating PolyradiculoneuropathyNeuromyelitis Optica Spectrum Disorders

Summary

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria5

  • 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 Criteria5

  • 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.

Interventions

DRUGUCAR T-cell

Universal allogeneic anti-CD19/BCMA CAR T-cells

Locations(1)

Tianjin Huanhu Hospital

Tianjin, China

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NCT06939166

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