The goal of this study is to evaluate the safety and efficacy of CD19 CAR T cells in the treatment of Refractory Autoimmune Diseases
1.Refractory Moderate-to-Severe Systemic lupus erythematosus (SLE) 1.1.Age 18-70 years. 1.2.Estimated life expectancy ≥ 3 months. 1.3.Documented disease history and diagnosis for ≥ 6 months prior to screening. 1.4.Participants must agree to use effective contraception throughout the study; women of child-bearing potential must have a negative pregnancy test.
Clinical manifestations: flaccid cutaneous bullae and fragile blisters that rupture easily, resulting in persistent erosions; mucosal blisters or erosions; positive Nikolsky sign.
Histopathology: intraepidermal or intraepithelial acantholysis.
Immunodiagnostic criteria: direct immunofluorescence (DIF) showing intercellular IgG and/or complement deposition in epidermal/epithelial cells of lesional or perilesional normal skin; positive serum anti-epithelial cell antibodies by indirect immunofluorescence; positive serum anti-desmoglein antibodies by ELISA.
(1) Clinically significant (as determined by the investigator) history of cardiac, endocrine, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic, or other major diseases.
Single group
CD19 CAR-T cells
Biological/VaccineFollowing lymphodepletion with chemotherapy (cyclophosphamide and fludarabine) patients will be treated with CD19 Chimeric Antigen Receptor (CAR) positive T cells as a single dose.
Phase I:Cytokine Release Syndrome (CRS)
The incidence and severity of Cytokine Release Syndrome (CRS)
Phase I：Immune Effector Cell-Associated Neurotoxicity Syndrome(ICANS)
The incidence and severity of Immune Effector Cell-Associated Neurotoxicity Syndrome(ICANS)
Phase II: Efficacy:Objective response rate (ORR)
Proportions of subjects achieving Autoimmune Diseases response
AUCS of CAR-T cells [Cell dynamics]
AUCS is defined as the area under the curve in 6 months
CMAX of CD19 CAR T cells [Cell dynamics]
CMAX is defined as the highest concentration of CD19 CAR T cells expanded in peripheral blood
TMAX of CD19 CAR T cells [Cell dynamics]
TMAX is defined as the time to reach the highest concentration
CAR-T proliferation [Cell dynamics]
the copy number of Senl CAR- T cells in the genomes of PBMC by qPCR method
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Hebei Senlang Biotechnology Inc., Ltd.
Lead sponsor
The Second Affiliated Hospital of Henan University of Traditional Chinese Medicine
Collaborator
Henan Province Engineering Technology Research Center of Immunological Precision Medicine and Artificial Intelligence Application, Luoyang, China
Collaborator
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