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A Study of C-CAR168 in the Treatment of 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 Autoimmune Diseases Refractory to Standard Therapy
Not yet recruitingPhase 1MS (type not specified)NCT07676266

What it found

Still running

No result yet.

What was tested

Treatment tested

  • CD20/BCMA-directed CAR-T cells Autologous 2nd generation

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 autoimmune diseases refractory to standard therapy

    Throughout the first 24 months follow up period completion

    Safety

Other measures (20)

  • 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

  • MS and NMOSD: Annualized Relapse Rate (ARR)

    Throughout the first 24 months follow up period completion

    Relapses

  • MG: Minimal Symptom Expression (MSE) and Minimal Clinically Important Difference (MCID)

    Throughout the first 24 months follow up period completion

  • MG: Quantitative Myasthenia Gravis Score (QMGS)

    Throughout the first 24 months follow up period completion

  • MG: Myasthenia Gravis Activities of Daily Living (MG-ADL) Scale

    Throughout the first 24 months follow up period completion

  • SLE: Definition Of Remission In SLE (DORIS), Lupus Low Disease Activity State (LLDAS), Systemic Lupus Erythematosus Responder Index-4 (SRI-4)

    Throughout the first 24 months follow up period completion

  • SLE: Systemic Lupus Erythematosus Disease Activity Index 2000(SLEDAI-2K),

    Throughout the first 24 months follow up period completion

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)/Myasthenia Gravis (MG)/Systemic Lupus Erythematosus (SLE)/ Systemic Sclerosis (SSc)/ Immune-Mediated Necrotizing Myopathy (IMNM) 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 for MS or NMOSD.

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 autoimmune diseases refractory to standard therapy

Papers

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    Related trials

    History

      1. Started

        Jul 2026

      2. Main results due

        Nov 2027

      3. Finished

        Oct 2028

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