A Clinical Study of CD19 CAR-T in Active Systemic Lupus Erythematosus

Trial details

Who runs it

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Trial code

NCT06106906

Record updated

8 January 2025

Original description

The purpose of the study is to explore the safety and efficacy of CD19 CAR-T in active systemic lupus erythematosus.Read full original descriptionShow less

A Single-center Clinical Study Evaluating the Safety and Efficacy of CD19 CAR-T in Active Systemic Lupus Erythematosus

The purpose of the study is to explore the safety and efficacy of CD19 CAR-T in active systemic lupus erythematosus.

Inclusion: Participants or their guardians understand and voluntarily sign the informed consent form, and be able to complete all the documents, procedures, follow-up examinations and treatments specified in the study protocol, with good compliance; Age range from 18 to 70 years old, regardless of gender; Body weight ≥ 40kg; Participants diagnosed with SLE according to the American College of Rheumatology (ACR) 1997 revised criteria for SLE at least 24 weeks prior to signing the informed consent form; Active SLE needs to meet the following criteria at screening:; SELENA-SLEDAI score ≥ 6 points; PGA ≥ 1 points; Have received at least 8 weeks of standardized treatment for SLE prior to screening; Female participants need to have a negative pregnancy test, and participants agree to take effective contraceptive measures throughout the study.

Exclusion: Diagnosis of active severe lupus nephritis within 8 weeks prior to screening, requiring medications prohibited by the research protocol for active nephritis, hemodialysis or prednisone ≥ 100 mg/d, or equivalent glucocorticoid therapy for ≥14 days; Presence of SLE or non-SLE related central nervous system diseases or pathological changes within 8 weeks prior to screening; Existence of other lupus crisis within 8 weeks prior to screening; Previous or current diagnosis of non-SLE-related inflammatory arthropathy or skin diseases; Previous or current diagnosis of severe vasculitis due to other diseases excluding SLE; Have received plasmapheresis, hemodialysis, intravenous immunoglobulin within 14 days prior to screening; Have received live/attenuated vaccination within 4 weeks prior to screening or plan to receive live/attenuated vaccination throughout the study; Have received any commercially available Janus kinase inhibitor or Bruton tyrosine kinase inhibitor within 3 half-lives prior to screening; Have received B-cell targeted therapy prior to screening; Have received a biologic agent other than B-cell targeted therapy within 5 half-lives prior to screening; Previous received therapies with CAR-T cells or other genetically modified T cells; Have received therapeutic dose of corticosteroids within 7 days prior to leukapheresis or within 72 hours prior to infusion; Have received any other study drugs for SLE within 4 weeks prior to leukapheresis; Subjects that have undergone major surgery within 4 weeks prior to lymph depletion or those who are scheduled to undergo major surgery during the study period, or whose surgical wounds have not fully healed prior to enrollment; Subjects that have donated blood for ≥ 400mL or had significant blood loss equivalent to at least 400mL within 4 weeks prior to screening, or have received a blood transfusion within 8 weeks, or plan to donate blood during the study period; History of ≥ grade 2 bleeding within 4 weeks prior to screening or need for long-term continuous anticoagulant therapy; Known hypersensitivity to prednisone, immunosuppressive agents; History of vital organ transplantation or hematopoietic stem cell/or bone marrow transplantation; Other autoimmune diseases requiring systemic therapy; Subjects with active viral hepatitis B; Subjects with positive hepatitis C virus (HCV) antibodies; Subjects with positive human immunodeficiency virus (HIV) antibodies; Sujects with positive extracellular DNA quantification of cytomegalovirus (CMV); Sujects with positive extracellular DNA quantification of EB virus (EBV);Subjects tested positive for syphilis; Active or latent tuberculosis at screening (can be enrolled if appropriately treated); History of severe allergy or known hypersensitivity to any of the active ingredients of the drugs, excipients, or rodent-derived products, xenoproteins included in this trial, or subjects with allergic constitution; Severe heart diseases; Severe hepatobiliary disease; Presence of medical conditions that are obviously unstable or not effectively treated; Presence of uncontrollable bacterial, fungal, viral or other infections, requiring antibiotic therapy; Subjects with severe mental illness; Alcoholics or subjects with a history of drug abuse; History of malignancy；; Patients that have contraindications to any of the study procedures or have other medical conditions that may expose them to unacceptable risk, in the judgment of the investigators and/or clinical criteria; Any of severe laboratory abnormalities in liver function, renal function, bone marrow function, coagulation function, pulmonary function, cardiac function at screening; Suicidal ideation within the past 6 months based on assessment by Columbia-Suicide Severity Rating Scale (C-SSRS) at screening; or any suicidal behaviors within the past 12 months or recurrent suicidal behaviors during the subject's lifetime; Female subjects who are pregnant or lactating, or intend to pursue pregnancy within 2 years after the cell infusion; male patients whose female sexual partners intend to conceive within 2 years after the cell infusion.

ClinicalTrials.gov NCT06106906