Anti-CD19/BCMA CAR-NK Cells in Patients With B Cell Mediated Autoimmune Disease (NCT06792799) | Clinical Trial Compass
RecruitingEarly Phase 1
Anti-CD19/BCMA CAR-NK Cells in Patients With B Cell Mediated Autoimmune Disease
China36 participantsStarted 2025-01-30
Plain-language summary
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.
Who can participate
Age range3 Years
SexALL
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Inclusion criteria
✓. 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% ;
Exclusion criteria
✕. Liver function: Asparagus cochinchinensis transase (AST) and Alanine Aminotransferase (ALT)≤3.0 ULN, Total Bilirubin (TBIL) in serum ≤2.0×ULN;
✕. Lung function: No serious lung lesions, SpO2≥92%;
✕. Negative pregnancy test for female Subjects of childbearing age, agree to take effective contraceptive measures the first year after CAR-NK infusion;
✕. Age:≥5 years old;
✕. Diagnosed with SLE according to the 2019 EULAR/ACR SLE classification criteria；
✕. Still in moderate to severe disease activity despite ≥3M of high dose glucocorticoids(prednisone≥1mg/kg/d or other equivalent amount of other steriod ), hydroxychloroquine and at least 2 of the following treatments(cyclophosphamide, MMF, azathioprine, methotrexate, cyclosporin, tacrolimus, sirolimus, leflunomide, telitacicept, Beliumab, and rituximab,etc,al); or Intolerant to standard treatments; or the dosage of steroid can not be reduced to 5mg/d after 6-month of routine treatment.
✕. SLEDAI 2K score\>6 points;
What they're measuring
1
The safety of CAR-NK cell therapy in patients with B cell mediated autoimmune disease
Timeframe: 1 months
2
The efficiency of CAR-NK cell therapy in patients with B cell mediated autoimmune disease
Timeframe: 3 months
Trial details
NCT IDNCT06792799
SponsorThe Children's Hospital of Zhejiang University School of Medicine