Ultra-fast autologous CD19 CAR-T therapy for refractory SLE

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 1, single-site interventional trial testing an ultra-fast autologous CD19-targeted CAR-T product produced with a rapid manufacturing system. Eligible adults with moderate to severe refractory SLE will undergo leukapheresis for T cell collection, rapid CAR-T preparation, and infusion, with close follow-up for safety and preliminary signs of clinical benefit. Primary outcomes focus on safety and tolerability, with secondary measures tracking disease activity (including SLEDAI-2K) and medication tapering. The protocol targets patients who have failed high-dose glucocorticoids and at least two disease-modifying agents.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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;
* Negative pregnancy test for female subjects of childbearing age, and agree to take effective contraceptive measures until one year after CAR-T infusion;
* Participant or his/her guardians agree to participate in the clinical trial and sign the informed consent form which indicating that he/she understands the purpose and procedure of the clinical trial and is willing to participate in the study.

Exclusion Criteria:

* 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;
* Received hematopoietic stem cell transplantation within 3 months prior to screening, or ≥Grade 2 GVHD within 2 weeks prior to screening;
* Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive and peripheral blood hepatitis B virus (HBV) DNA titer greater than the normal reference value range; or hepatitis C virus (HCV) antibody positive and peripheral blood hepatitis C virus (HCV) RNA titer greater than the normal reference value range; or positive for human immunodeficiency virus (HIV) antibodies; or syphilis test positive;
* Suffered from active pulmonary tuberculosis at screening;
* Received live vaccine within 4 weeks prior to screening;
* Positive in blood pregnancy test;
* Suffered from malignant disease such as tumors (excluding tumors without active lesions and ending treatment for more than 5 years, as well as fully treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, thyroid cancer after radical resection, ductal carcinoma in situ after radical resection);
* Patients who participated in other clinical study within 3 months prior to screening;
* Any other conditions that the investigators deem it unsuitable for the study.

Where it's running

• Affiliated Drum Tower Hospital, Medical School of Nanjing University
  Nanjing, Jiangsu, China Recruiting

Study contacts

• Study coordinator: Lingyun Sun
• Email: lingyunsun2012@163.com
• Phone: 13705186409

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.