Evaluating the efficacy and safety of anti-CD19/BCMA CAR-NK Cells in Paediatric B cell-related autoimmune diseases
Informed consent: The participant (and guardian if the participant is a minor) must provide written informed consent, indicating understanding of the study purpose and procedures and willingness to participate.
Cardiac Function: Echocardiography shows no significant structural abnormalities and left ventricular ejection fraction (LVEF) ≥ 55%.
Hepatic Function: ALT ≤ 3 × ULN (except when elevation is attributable to inflammatory myopathy); AST ≤ 3 × ULN (except when elevation is attributable to inflammatory myopathy); Total bilirubin ≤ 2.0 × ULN (≤ 3.0 × ULN allowed for Gilbert syndrome).
Renal Function: eGFR ≥ 30 mL/min/1.73 m².(Participants with eGFR < 30 mL/min/1.73 m² and/or those receiving renal replacement therapy may be considered eligible if, in the investigator's judgment, the potential benefit outweighs the risk and the participant or guardian provides fully informed consent.)
Subjects with known severe allergic reactions, hypersensitivity, contraindication to any medications during the trial (cyclophosphamide, tocilizumab), or subjects with a history of severe allergic reactions.
Uncontrollable infection, or active infection that requires systemic treatment at screening.
Subjects with grade III or IV heart failure (NYHA classification).
Have a history of congenital heart disease or acute myocardial infarction within 6 months prior to screening; Or severe arrhythmias (including multisource frequent supraventricular tachycardia, ventricular tachycardia, etc.); Or combined with moderate to massive pericardial effusion, serious myocarditis, etc; Or patients with unstable vital signs who need hypertensive drugs.
Single group
anti-CD19/BCMA CAR NK cells (KN5601-K)
Biological/VaccineThe study adopted a dose-escalation and expansion study design. All subjects will receive fludarabine/ cyclophosphamide lymphodepletion followed by anti-CD19/BCMA CAR NK cells infusion.
Incidence and severity of dose-limiting toxicity (DLT) and treatment-emergent adverse events (TEAEs)
The safety of CAR-NK cell therapy in patients with B cell mediated autoimmune disease
response rate
The Efficacy of CAR-NK cell therapy in patients with SLE, MDR-SRNS, IgA nephropathy, or ANCA-AAV
CRISS score
The Efficacy of CAR-NK cell therapy in patients with Systemic Sclerosis
Complete response or partial response rate
The Efficacy of CAR-NK cell therapy in patients with SLE, MDR-SRNS, IgA nephropathy, or ANCA-AAV, SSC
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The Children's Hospital of Zhejiang University School of Medicine
Lead sponsor
Rui Therapeutics
Collaborator
