MSFrontier

CAR-AID

An Exploratory Clinical Study of Cluster of Differentiation Antigen 20(CD20)/Anti-B-cell Maturation Antigen(BCMA) Chimeric Antigen Receptor Autologous T Cell Product (C-CAR168) in the Treatment of Autoimmune Diseases Refractory to Standard Therapy
RecruitingPhase 1MS (type not specified)NCT06249438

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 of Adverse Events [Safety and Tolerability]

    Throughout the first 24 months follow up period completion (3 years)，DLTs will be observed/collected throughout the 28 days post C-CAR168 infusion

    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 (3 years)

    Safety

Other measures (14)

  • The proportion of subjects who achieved remission at 6 months (6M)

    Throughout the first 6 months follow up period completion (1.5 years)

  • The proportion of subjects who achieved remission during the main study period

    Throughout the first 24 months follow up period completion (3 years)

  • The proportion of subjects who experienced relapse during the main study period

    Throughout the first 24 months follow up period completion (3 years)

    Relapses

  • Time to response (TTR)

    Throughout the first 24 months follow up period completion (3 years)

  • Progression-free survival (PFS)

    Throughout the first 24 months follow up period completion (3 years)

  • The proportion of subjects who achieved glucocorticoids/immunosuppressant free and subjects who achieved low-dose glucocorticoids application during the main study period

    Throughout the first 24 months follow up period completion (3 years)

  • Maximal plasma concentration (Cmax)

    Throughout the first 24 months follow up period completion (3 years)

    How the body handles the medicine

  • Time to reach the maximal plasma concentration (Tmax)

    Throughout the first 24 months follow up period completion (3 years)

    How the body handles the medicine

  • Duration in peripheral blood (Tlast)

    Throughout the first 24 months follow up period completion (3 years)

  • Area under curve (AUC)

    Throughout the first 24 months follow up period completion (3 years)

    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 SLE/Immune-Mediated Necrotizing Myopathy (IMNM)/Neuromyelitis Optica Spectrum Disorders (NMOSD)/Multiple Sclerosis (MS)/Myasthenia Gravis (MG)/Systemic Sclerosis (SSc) according to recognized diagnostic criteria for at least 6 months. * Remains disease active or relapses after treatment with standard of care therapy for at least 8 weeks with the dose stable for more than 2 weeks; patients should have been treated with at least two immunosuppressants (including immunosuppressants, biologics, and disease-modifying drug (DMD) ). * 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. * ≥ Grade 2 bleeding within the past 30 days 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.

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, multicenter, 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

        Mar 2024

      2. Main results due

        Mar 2027

      3. Finished

        Mar 2040

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