Study of Ultra-Fast BCMA/CD70 CAR-T Therapy for Refractory SLE
Recruiting now · Phase 1
Conditions studied: Systemic Lupus Erythematosus
In brief
This is an investigator-initiated trial aimed at assessing the safety and efficacy of ultra-fast autologous BCMA/CD70-targeted CAR-T cells in the treatment of refractory systemic lupus erythematosus.
Key facts
- Study ID
- NCT07318259
- Run by
- Chongqing Precision Biotech Co., Ltd
- People needed
- 18
- Starts
- 2026-01-26
- Expected to finish
- 2028-08-01
- Last updated by the study team
- 2026-02-03
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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 is running
- Affiliated Drum Tower Hospital, Medical School of Nanjing University — Nanjing, Jiangsu, China (enrolling)
Full record on ClinicalTrials.gov
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