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.
Age: ≥ 18 years old and ≤ 70 years old, male or female;
Subject have previous diagnosis of systemic lupus erythematosus (SLE) (according to the 1997 American College of Rheumatology revised SLE classification criteria, the 2012 Systemic Lupus International Collaborating Clinics classification criteria, or the 2019 European League Against Rheumatism/American College of Rheumatology joint classification criteria);
Subjects had a modified SLEDAI-2K score of ≥8 at screening;
Subject has ≥ 1 organ system with BILAG-2004 Class A mobility score or ≥ 2 organ systems with BILAG-2004 Class B mobility score at screening;
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;
Single group
anti-CD19/BCMA U CAR T cells
Biological/VaccinePatients will receive Fludarabine and Cyclophosphamide on day-5, -4, and -3. Dose escalation will be performed for the single dose injection of anti-CD19/BCMA CAR T cells (KN3601)
Incidence of Dose-Limiting Toxicity (DLT)
To characterize the safety of anti-CD19/BCMA U CAR T Cells (KN3601) for patients with Relapsed/Refractory autoimmune diseases
Incidence of Treatment Emergent Adverse Events (TEAEs)
To characterize the safety of anti-CD19/BCMA U CAR T Cells (KN3601) for patients with Relapsed/Refractory autoimmune diseases
The overall response rate (ORR)
To characterize the efficacy of anti-CD19/BCMA U CAR T Cells (KN3601) for patients with Relapsed/Refractory autoimmune diseases
Disease control rate (DCR)
To characterize the efficacy of anti-CD19/BCMA U CAR T Cells (KN3601) for patients with Relapsed/Refractory autoimmune diseases
B cell depletion rate
To characterize the efficacy of anti-CD19/BCMA U CAR T Cells (KN3601) for patients with Relapsed/Refractory autoimmune diseases
B cell reconstitution
B cell subsets in peripheral blood measured by flow cytometry
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Changhai Hospital
Lead sponsor
Rui Therapeutics Co., Ltd
Collaborator
