Exploratory Clinical Study on the Safety and Efficacy of Anti- CD19/BCMA CAR-NK Cell Injection fo… (NCT07490041) | Clinical Trial Compass
RecruitingEarly Phase 1
Exploratory Clinical Study on the Safety and Efficacy of Anti- CD19/BCMA CAR-NK Cell Injection for the Treatment of Refractory Pediatric Rheumatic Diseases
China36 participantsStarted 2026-03-19
Plain-language summary
A single arm, open-label pilot study is designed to determine the safety and effectiveness of anti-CD19/BCMA CAR-NK cell injection in patients with refractory pediatric rheumatic diseases.
Who can participate
Age range5 Years
SexALL
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Inclusion criteria
✓. . Gender unrestricted, age ≥5 years;
✓. . The patient or their legal guardian agrees to participate in this clinical trial and signs the informed consent form, indicating their understanding of the trial's purpose and procedures and willingness to participate;
✓. . Peripheral blood B cells confirmed by flow cytometry to express CD19, with a B cell count \>5 cells/uL;
✓. . If previously treated with B cell-targeted therapy, peripheral blood B cell count at screening has returned to normal or above the pre-treatment level;
✓. . Echocardiography indicates basically normal cardiac structure and left ventricular ejection fraction (LVEF) ≥55%; electrocardiogram shows no significant abnormalities;
✓. . Liver function: aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3.0×ULN, total bilirubin (TBIL) ≤2.0×ULN;
✓. . Renal function: estimated glomerular filtration rate (eGFR) ≥30 mL/min/1.73m²; (If eGFR \<30 mL/min/1.73m² and/or undergoing renal replacement therapy, the subject may be considered for enrollment after the investigator's assessment that the benefit outweighs the risk and with full informed consent from the patient/guardian);
✓. . Pulmonary function: No severe pulmonary lesions, blood oxygen saturation (SpO₂) ≥92%;
Exclusion criteria
✕. . History of malignancy (except for basal cell or squamous cell skin cancer or carcinoma in situof the cervix that has been excised and cured for at least 5 years), or current malignancy.
What they're measuring
1
Incidence of Dose-Limiting Toxicity (DLT)
Timeframe: up to 28 days after infusion
Trial details
NCT IDNCT07490041
SponsorThe Children's Hospital of Zhejiang University School of Medicine
. . Known allergy, hypersensitivity, intolerance, or contraindication to CD19/BCMA CAR-NK cells or any component of the drugs that may be used in the study (including fludarabine, cyclophosphamide, and tocilizumab), or subjects who have experienced a severe allergic reaction in the past.
✕. . Evidence of severe active viral or bacterial infection, or uncontrolled systemic fungal infection at screening or baseline visits, or subjects with active or uncontrolled infection requiring parenteral antimicrobial therapy.
✕. . Subjects with cardiac insufficiency classified as Class III or IV according to the New York Heart Association (NYHA) functional classification (see Appendix).
✕. . Subjects with congenital heart disease, or history of acute myocardial infarction within 6 months prior to screening, or severe arrhythmia (including multifrequent ventricular premature beats, supraventricular tachycardia, ventricular tachycardia, etc.); or combined with moderate to large pericardial effusion, severe myocarditis, etc.; or unstable vital signs requiring vasopressors to maintain blood pressure.
✕. . Positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with detectable hepatitis B virus (HBV) DNA levels above the normal reference range in peripheral blood at screening; OR positive hepatitis C virus (HCV) antibody with detectable HCV RNA levels above the normal reference range; OR positive human immunodeficiency virus (HIV) antibody; OR positive syphilis test; OR positive cytomegalovirus (CMV) DNA test.
✕. . History of severe herpes infection, such as herpes encephalitis, ocular herpes, or disseminated herpes; signs of herpes or varicella-zoster virus infection (particularly varicella, herpes zoster) within 12 weeks prior to screening.
✕. . Current active tuberculosis or history of active tuberculosis, or subjects whose interferon-gamma release assay for tuberculosis infection cannot yield a negative result during the screening period.