Study of Ultra-Fast CD19 CAR-T Therapy for Refractory SLE
ConditionSystemic Lupus Erythematosus
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorChongqing Precision Biotech Co., Ltd
About this trial
This is an investigator-initiated trial aimed at assessing the safety and efficacy of ultra-fast autologous CD19-targeted CAR-T cells in the treatment of refractory systemic lupus erythematosus.
Eligibility criteria
Qualifiers
Age ≥ 18 years old;
Diagnosed with SLE according to the 2019 EULAR/ACR SLE classification criteria, and still in moderate to severe disease activity despite ≥3M of high dose glucocorticoids(prednisone≥1mg/kg/d or other equivalent amount of other steriod), and/or hydroxychloroquine, and at least 2 DMARDs(include cyclophosphamide, mycophenolate mofetil, azathioprine, methotrexate, cyclosporin, tacrolimus, sirolimus, leflunomide, telitacicept, beliumab, and rituximab) or intolerant to standard treatments;
SLEDAI-2K score ≥ 8 points;
Meet the standards of leukapheresis or intravenous blood collection, and no contraindication for leukapheresis;
Disqualifiers
Central nervous system (CNS) disease: CNS neurolupus requires intervention within 30 days;
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 NYHA classification class IV; or combined with moderate to massive pericardial effusion, serious myocarditis, etc; or patient with unstable vital signs who need hypertensive drugs;
The functions of important organs meet one of the following conditions: (1)renal function: eGFR<30mL/min/1.73m2 or require renal replacement therapy; (2)liver function: AST and ALT>3.0 ULN, total Bilirubin (TBIL) in serum >2.0×ULN; (3)lung function: SpO2<92% with no oxygen inhalation;
Uncontrollable infection or active infection that requires systemic treatment within 3 months prior to screening;
Trial design
Treatments tested in this trial
- CD19 CAR-T cells
Treatment groups
18 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov