Exploratory Clinical Study on the Safety and Efficacy of Anti- CD19/BCMA U CAR-T Cell Injection for the Treatment of Relapsed/Refractory Autoimmune Diseases

Recruiting now · Early Phase 1

Conditions studied: Autoimmune Diseases, Systemic Lupus Erythematosus, Systemic Sclerosis, Primary Sjögren Syndrome, Rheumatoid Arthritis, Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis

In brief

A single arm, open-label pilot study is designed to determine the safety and effectiveness of anti-CD19/BCMA U CAR T cells in patients with autoimmune diseases. 60 patients are planned to be enrolled in the dose-escalation trial.

Key facts

Study ID

NCT07246096

Run by

Changhai Hospital

People needed

60

Starts

2026-02-20

Expected to finish

2028-07-20

Last updated by the study team

2026-02-25

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Subjects who meet any of the following common exclusion criteria or disease-specific exclusion criteria will not be eligible for this study.
• Common exclusion Criteria:
• Subjects with known severe allergic reactions, hypersensitivity, contraindication to any medications during the trial (cyclophosphamide, fludarabine, tozumabs), or subjects with a history of severe allergic reactions;
• Existence or suspicion of uncontrollable or treatable fungal, bacterial, viral or other infections;
• Subjects with central nervous system disorders caused by ADs or not caused by ADs (including epilepsy, psychiatric disorders, organic encephalopathy syndromes, cerebrovascular accidents, encephalitis, central nervous system vasculitis);
• Subjects s with relatively serious heart diseases, such as angina pectoris, myocardial infarction, heart failure, and arrhythmia;
• Subjects with congenital immunoglobulin deficiency;
• Subjects with malignant tumors (except for non-melanoma skin cancer and in situ cervical, bladder, and breast cancers that have been disease free for more than 5 years);
• Subjects with end-stage renal failure;
• Subjects with positive hepatitis B surface antigen (HBsAg) or hepatitis,B core antibody (HBcAb) and HBV DNA titer in peripheral blood higher than the upper limit of detection; Patients with positive hepatitis C virus (HCV) antibodies and positive peripheral blood HCV RNA; People who are positive for human immunodeficiency virus (HIV) antibodies; Those who have tested positive for syphilis;
• Subjects with mental illness and severe cognitive impairment;
• Subjects who have received other clinical trial treatment within 6 months;
• Pregnant or intending to conceive women;
• Subjects with hypertension or diabetes that cannot be controlled by medication;
• In the opinion of the investigator, there are other reasons that prevent some subjects from being included in this study.
• Specific exclusion Criteria:
• Relapsed/Refractory Systemic lupus erythematosus
• Except for SLE, any clinically significant history of cardiac, endocrine, blood, liver, immune, metabolic, urinary, pulmonary, neurological, skin, psychiatric, or renal disorders, or other major diseases that may interfere with the administration of KN3601 (as determined by the investigator);
• Except for SLE, any active skin disease that could interfere with the research evaluation of SLE including but not limited to psoriasis, dermatomyositis, systemic sclerosis, non-SLE cutaneous lupus manifestations (such as cutaneous vasculopathy, periungual capillary dilation, fingertip sclerosis, rheumatoid nodules, erythema multiforme, leg ulcers) or drug-induced lupus.
• Relapsed/Refractory Primary Sjögren's Syndrome
• SSc-like disease caused by environmental, ingestion, or injection factors, accompanied by other autoimmune diseases (such as systemic lupus erythematosus, rheumatoid arthritis, polymyositis, etc.).
• Relapsed/Refractory dry syndrome
• Combined cirrhosis of the liver;
• Combination of aplastic anemia (AA), myelodysplastic syndrome (MDS), or other myeloproliferative disease (MPD).
• Relapsed/Refractory rheumatoid arthritis

Where it is running

• Changhai Hospital — Shanghai, China (enrolling)

Full record on ClinicalTrials.gov

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