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A Study of C-CAR168 in the Treatment of Central Nervous System Autoimmune Diseases Refractory to Standard Therapy

An Exploratory Clinical Study of Anti-CD20/B-cell Maturation Antigen(BCMA) Chimeric Antigen Receptor Autologous T Cell Product (C-CAR168) in the Treatment of Central Nervous System Autoimmune Diseases Refractory to Standard Therapy
Not yet recruitingPhase 1MS (type not specified)NCT07341828

What it found

Still running

No result yet.

What was tested

Treatment tested

  • CD20/BCMA-directed CAR-T cells

What it measured

Main measures

  • Incidence and severity of Adverse Events [Safety and Tolerability]

    Throughout the first 3 months follow up period completion

    Safety

  • The subsequent recommended dose of C-CAR168 in patients with central nervous system autoimmune diseases refractory to standard therapy

    Throughout the first 24 months follow up period completion

    Safety

Other measures (14)

  • Incidence and severity of adverse events (AE)

    Throughout the first 24 months follow up period completion

    Safety

  • MS: No Evidence of Disease Activity-3 (NEDA-3)

    Throughout the first 24 months follow up period completion

  • MS and NMOSD: Expanded Disability Status Scale (EDSS)

    Throughout the first 24 months follow up period completion

    Disability progressionBladder, bowel and sexual function

  • MS and NMOSD: MRI

    Throughout the first 24 months follow up period completion

    MRI lesionsBrain volume loss

  • Autoimmune Encephalitis (AiE): Clinical Assessment Scale in Autoimmune Encephalitis (CASE)

    Throughout the first 24 months follow up period completion

  • MS, NMOSD and AiE: Annualized Relapse Rate (ARR)

    Throughout the first 24 months follow up period completion

    Relapses

  • Stiff-Person Syndrome (SPS): Distribution of Stiffness Index (DSI)

    Throughout the first 24 months follow up period completion

  • SPS: Heightened Sensitivity Score (HSS)

    Throughout the first 24 months follow up period completion

    Spasticity

  • Pharmacokinetics (PK): Maximal plasma concentration (Cmax)

    Throughout the first 24 months follow up period completion

    How the body handles the medicine

  • PK: Time to reach the maximal plasma concentration (Tmax)

    Throughout the first 24 months follow up period completion

    How the body handles the medicine

Who could take part

MS (type not specified) · 18 to 70

Inclusion Criteria: * 18 to 70 years old at the time of signing the Informed Consent Form (ICF). * Diagnosed as Multiple Sclerosis (MS)/Neuromyelitis Optica Spectrum Disorders (NMOSD)/Autoimmune Encephalitis(AiE)/Stiff Person Spectrum Disorder(SPSD) according to recognized diagnostic criteria for at least 6 months. * Prior treatment failure with standard therapy. * Adequate bone marrow, coagulation, cardiopulmonary, liver and renal function. Exclusion Criteria: * Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Human Immunodeficiency Virus (HIV), Treponema Pallidum (TP) positive, Cytomegalovirus (CMV) DNA positive, Epstein-Barr Virus (EBV) DNA positive. * Uncontrolled active infection. * Live vaccine injection within 4 weeks prior to signing the ICF. * Major organ transplantation history or bone marrow/hematopoietic stem cell transplantation history. * Severe cardiovascular diseases within the past 6 months prior to screening. * A history of ≥ Grade 2 bleeding within 4 weeks prior to screening, or requiring long-term anticoagulants treatment. * Inadequate washing time for previous treatment. * Previously treated with CAR-T cell products or genetically modified T cell therapies. * Pregnant or lactating women. * Severe central nervous system diseases or pathological changes. * Malignancy history within 5 years prior to signing the ICF. * Any contraindication to lumbar puncture.

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 investigator-initiated, single-center, open-label study of C-CAR168, an autologous bi-specific CAR-T therapy targeting CD20 and BCMA, for the treatment of adult patients with central nervous system autoimmune diseases refractory to standard therapy

Papers

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    Related trials

    History

      1. Started

        Feb 2026

      2. Main results due

        Jun 2027

      3. Finished

        Feb 2029

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