Anti-CD19/BCMA CAR-NK Cells in Patients With B Cell Mediated Autoimmune Disease

Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age3+
SponsorThe Children's Hospital of Zhejiang University School of Medicine

About this trial

this is an investigator-initiated trial aimed at evaluating the efficacy and safety of anti-CD19/BCMA CAR-NK Cells in Patients With B cell mediated autoimmune disease.

Eligibility criteria

Qualifiers

Patients or their legal guardians must acknowledge the risks and procedures involved and subsequently provide informed consent to participate in the clinical trial.

Predicted survival time ≥ 12 weeks;

ECOG: 0~2;

Cardiac function: Left ventricular ejection fraction (LVEF) ≥55% ;

Disqualifiers

Subjects with known severe allergic reactions, hypersensitivity, contraindication to any medications during the trial (cyclophosphamide, fludarabine, obinutuzumab), or subjects with a history of severe allergic reactions

Uncontrollable infection, or active infection that requires systemic treatment within 1 week prior to 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;

Trial design

Treatments tested in this trial

  • anti-CD19/BCMA CAR NK cells (KN5601)

Treatment groups

36 Participants
are divided into 1 treatment group