Universal Chimeric Antigen Receptor T-Cell （UCAR T-cell） Therapy Targe

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

RecruitingEarly phase 1MS (type not specified)NCT06939166

What it found

Still running

No result yet.

What was tested

Treatment tested

  • UCAR T-cell

What it measured

Main measures

  • The number and severity of dose-limiting toxicity (DLT) events

    Within 28 Days After UCAR T-cell Infusion

    Immune responseSafety

  • The total number, incidence, and severity of AEs

    Up to 90 days After UCAR T-cell Infusion

Other measures (6)

  • NMOSD、MS: Expanded Disability Status Scale (EDSS) score

    Up to 24 Months After UCAR T-cell Infusion

    Disability progressionBladder, bowel and sexual function

  • NMOSD、MS: Modified Rankin Scale

    Up to 24 Months After UCAR T-cell Infusion

  • MG: Quantitative Myasthenia Gravis Score (QMG)

    Up to 24 Months After UCAR T-cell Infusion

  • MG: Myasthenia Gravis Activities if Daily Living (MG-ADL) Score

    Up to 24 Months After UCAR T-cell Infusion

  • CIDP: Inflammatory Neuropathy Cause and Treatment (INCAT) Score

    Up to 24 Months After UCAR T-cell Infusion

  • AE: Change in CASE

    Up to 24 Months After UCAR T-cell Infusion

Who could take part

MS (type not specified) · 18 and over

Show the full 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.

As registered. Criteria can change, so ask the trial team or your neurologist.

Contact details on the registry

About this trial

In the sponsor's words

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.

Papers

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    History

      1. Started

        Jun 2025

      2. Main results due

        Apr 2026

      3. Finished

        Oct 2027

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