Cluster of Differentiation 19 (CD19)/B Cell Maturation Antigen (BCMA) Chimeric Antigen Receptor T-Cell (CAR-T) Therapy for Refractory Autoimmune Diseases
China20 participantsStarted 2026-03-22
Plain-language summary
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.
Who can participate
Age range18 Years – 70 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Age: 18\~70 years old, male or female; provided written informed consent form (ICF).
✓. Diagnosis of one of the following diseases:
✓. 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;
✓. Dermatomyositis (DM), meeting the 1975 Bohan and Peter criteria for DM or the 2020 European Neuromuscular Centre (ENMC)-DM classification criteria;
✓. Antisynthetase syndrome (ASS), meeting the 2010 Conners classification criteria or the 2011 Solomon classification criteria;
✕. 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;
✕. Positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with peripheral blood hepatitis B virus (HBV) DNA titer above the normal reference range;or positive for hepatitis C virus (HCV) antibody with peripheral blood HCV RNA titer above the normal reference range;or positive for human immunodeficiency virus (HIV) antibody;or positive for syphilis;or positive for cytomegalovirus (CMV) DNA;
✕. Administration of live vaccines within 4 weeks prior to screening;
✕. Positive pregnancy test;
✕. Patients with malignant tumors or other malignant diseases prior to screening, excluding adequately treated carcinoma in situ of the cervix, basal cell or squamous cell skin cancer, localized prostate cancer after radical treatment, and ductal carcinoma in situ after radical surgery;