Not yet recruitingEarly phase 1MS (type not specified)NCT06485232

What it found

Still running

No result yet.

What was tested

Treatment tested

  • Universal BCMA CAR-T
  • Universal CD19 CAR-T
  • Universal BCMA CAR-T; Universal CD19 CAR-T

What it measured

Main measures

  • Incidence of dose-limiting toxicities(DLTs)

    First 28 days after infusion

    Safety
  • Incidence of adverse events(AEs) and severe adverse

    Up to 12 months after infusion

    Safety

Other measures (8)

  • Concentrations of UCAR-T cells

    3 months

    Immune response
  • B cell levels in peripheral blood

    3 months

    Immune response
  • Changes of pathogenic antibody titers after infusion

    1, 3, 6 ,12months

    Blood or spinal fluid markersImmune response
  • NMOSD: Annualized relapse rate

    6, 12months

    Relapses
  • gMG: Changes of Myasthenia Gravis Activities if Daily Living (MG-ADL) Score

    1, 3, 6, 12months

  • CIDP:Changes of Inflammatory Neuropathy Cause and Treatment (INCAT) Score after infusion.

    1, 3, 6, 12months

    Walking and mobilityArm and hand function
  • MS: Changes of the number of Gd-enhancing T1 Lesions

    6, 12months

    MRI lesions
  • MS: Changes of the number of Number of New or Enlarging T2 Lesions

    6, 12months

    MRI lesions

Who could take part

MS (type not specified) · 18 to 75

Inclusion Criteria: * Aged 18-75 years (for MS patients, 18-55 years); both genders eligible. * Subjects with refractory neurological autoimmune diseases who have failed standard treatment or lack effective treatment, Including neuromyelitis optica spectrum disorders(NMOSD), generalized myasthenia gravis(gMG), chronic inflammatory demyelinating Polyradiculoneuropathy(CIDP) and multiple sclerosis(MS). * Anticipated survival of ≥ 12 weeks as judged by the researcher. * Agrees to use double barrier methods, condoms, oral or injectable contraceptives, or intrauterine devices during the study period and for one year after taking the study medication. * Provides written informed consent. Exclusion Criteria: * History of solid organ transplantation. * Malignant tumor within the last two years. * Positive for Hepatitis B surface antigen (HBsAg) or Hepatitis B core antibody (HBcAb), with peripheral blood Hepatitis B virus (HBV) DNA detected as positive; positive for Hepatitis C virus antibodies, with peripheral blood Hepatitis C virus RNA detected as positive; positive for Human Immunodeficiency Virus (HIV) antibodies; positive for Cytomegalovirus (CMV) DNA; positive for syphilis. * Primary immunodeficiency (congenital or acquired). * Severe cardiac disease. * History of psychiatric disorders or history of psychotropic drug abuse, with no history of withdrawal. * Allergic constitution or a history of severe allergies. * Pregnant or breastfeeding women.

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 25 participants with refractory autoimmune diseases of nervous system. This study aims to evaluate the safety and efficacy of the treatment with universal BCMA and CD19 CART.

Papers

    Loading reviews and guidelines…

    Related trials

    History

      1. Started

        Feb 2025

      2. Main results due

        Dec 2026

      3. Finished

        Dec 2027

      Assembled by software from public sources and not checked by people. Each record links to its source. Report an error