Phase
Condition
Systemic Lupus Erythematosus
Collagen Vascular Diseases
Connective Tissue Diseases
Treatment
CD20/BCMA-directed CAR-T cells
Clinical Study ID
Ages 18-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 OpticaSpectrum Disorders (NMOSD)/Multiple Sclerosis (MS)/Myasthenia Gravis (MG) accordingto recognized diagnostic criteria for at least 6 months.
Remains disease active or relapses after treatment with standard of care therapy forat least 8 weeks with the dose stable for more than 2 weeks; patients should havebeen treated at least two immunosuppressants (immunosuppressants ordisease-modifying drug (DMD) for MS participants).
Adequate bone marrow, coagulation, cardiopulmonary, liver and renal function.
Exclusion
Exclusion Criteria:
Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Human Immunodeficiency Virus (HIV), Treponema Pallidum (TP) positive, Cytomegalovirus (CMV) 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 celltransplantation history.
Severe cardiovascular diseases within the past 6 months prior to screening.
≥ Grade 2 bleeding within the past 30 days prior to screening, or requiringlong-term anticoagulants treatment.
Inadequate washing time for previous treatment.
Previously treated with CAR-T cell products or genetically modified T celltherapies.
Pregnant or lactating women.
Severe central nervous system diseases or pathological changes.
Malignancy history within 5 years prior to signing the ICF.
Study Design
Connect with a study center
Department of Rheumatology, RenJi Hospital, School of Medicine, Shanghai JiaoTong University
Shanghai, Shanghai 200001
ChinaActive - Recruiting
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