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RECRUITINGPhase 1INTERVENTIONAL

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

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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

Who May Be Eligible (Plain English)

Who May Qualify: - 18 to 70 years old at the time of signing the willing to sign a consent form 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. Who Should NOT Join This Trial: - Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Human weakened immune system 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

BIOLOGICAL

CD20/BCMA-directed CAR-T cells

Autologous 2nd generation CD20/BCMA-directed CAR-T cells, single infusion intravenously

Locations (1)

Department of Rheumatology, RenJi Hospital, School of Medicine, Shanghai JiaoTong University
Shanghai, Shanghai Municipality, China