NCT07331467 Study of Ultra-Fast CD19 CAR-T Therapy for Refractory SLE
| NCT ID | NCT07331467 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Chongqing Precision Biotech Co., Ltd |
| Condition | Systemic Lupus Erythematosus |
| Study Type | INTERVENTIONAL |
| Enrollment | 18 participants |
| Start Date | 2026-01 |
| Primary Completion | 2026-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 18 participants in total. It began in 2026-01 with a primary completion date of 2026-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07331467 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Systemic Lupus Erythematosus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07331467 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07331467 currently recruiting?
Yes, NCT07331467 is actively recruiting participants. Contact the research team at lingyunsun2012@163.com for enrollment information.
Where is the NCT07331467 trial being conducted?
This trial is being conducted at Nanjing, China.
Who is sponsoring the NCT07331467 clinical trial?
NCT07331467 is sponsored by Chongqing Precision Biotech Co., Ltd. The trial plans to enroll 18 participants.
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