This study is an investigator-initiated single center, single arm clinical study with a target population of patients with refractory autoimmune diseases. It is an early exploratory clinical study of the safety, tolerability and initial efficacy of CD19/BCMA CAR-T in the treatment of refractory autoimmune diseases.
Age: 18~70 years old, male or female; provided written informed consent form (ICF).
Systemic lupus erythematosus (SLE), diagnosed according to the European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) 2019 criteria, with Antinuclear Antibody (ANA) > 1:80 or positive anti-dsDNA antibody;
Sjögren's syndrome (SS), diagnosed according to the 2016 ACR/EULAR criteria, with at least positive anti-Sjögren's-syndrome-related antigen A antibody (SSA) antibody;
Systemic sclerosis (SSc), diagnosed according to the 2013 ACR/EULAR criteria, with ANA > 1:80 or positive anti-Scleroderma (SCL)-70 antibody;
Prior treatment with CAR-T cell therapy;
Suffering from severe cardiac, hepatic, pulmonary, hematological, or endocrine diseases, for whom the investigator determines that the risks of participation outweigh the benefits;
Active infection requiring systemic therapy or uncontrolled infection within 1 week prior to screening;
Prior hematopoietic stem cell transplantation or solid organ transplantation (excluding corneal and hair transplantation), or acute graft-versus-host disease (GVHD) of Grade 2 or higher within 2 weeks prior to screening;
Single group
CD19/BCMA-targeted CAR-T lentiviral vector drug
DrugThe CD19/BCMA-targeted CAR-T lentiviral vector drug is administered intravenously, and autologous CD19/BCMA-targeted CAR-T cells are produced in the patient's body following infusion.
Incidence of adverse events(AE) after infusion
The frequency, severity, and laboratory findings of all adverse events/serious adverse events are included.
Maximal Tolerated Dose(MTD)
MTD will be determined based on Dose-Limiting Toxicity(DLTs) observed during the first 28 days of study treatment.
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Liang Zou
Lead sponsor
Wuhan Integrated Traditional Chinese and Western Medicine Hospital
Sponsor institution
