Study of BCMA/CD70 CAR-T Therapy for Refractory cSLE
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age5+
SponsorThe Children's Hospital of Zhejiang University School of Medicine
About this trial
This is an investigator-initiated trial aimed at assessing the safety and efficacy of anti-BCMA/CD70 CAR-T cells in the treatment of refractory systemic lupus erythematosus.
Eligibility criteria
Qualifiers
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); or Intolerant to standard treatments;
SLEDAI 2K score≥8 points;
The functions of important organs are as follows: Cardiac function: Left ventricular ejection fraction (LVEF) ≥55% with no obvious abnormality in electrocardiogram; Renal function: eGFR≥30ML/min/1.73m2；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%;
Disqualifiers
Central nervous system (CNS) disease: CNS neurolupus requires intervention within 60 days);
Severe acute nephritis: Patients who have accepted or was undergoing renal replacement therapy within 3 months prior to transfusion; Or in the investgator's opinion, patients who is likely to have significant kidney disease within 3 moths of the study which need high dose glucocorticoid (prednisone dose≥1mg/kg/day or equivalent amount of other steriod), cyclophosphamide, or MMF treatment;
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；
Suffer from other diseases that require long-term use of glucocorticoid or high-dose of immunosuppressive agents;
Trial design
Treatments tested in this trial
- anti-BCMA/CD70-CAR-T cells
Treatment groups
18 Participants
are divided into 1 treatment groupSponsors and collaborators
The Children's Hospital of Zhejiang University School of Medicine
Lead sponsor
Chongqing Precision Biotech Co., Ltd
Collaborator
Source ClinicalTrials.gov