NCT07403097 Study of CD19 CAR-T Therapy for Refractory SLE
| NCT ID | NCT07403097 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Chongqing Precision Biotech Co., Ltd |
| Condition | Systemic Lupus Erythematosus |
| Study Type | INTERVENTIONAL |
| Enrollment | 18 participants |
| Start Date | 2026-02 |
| Primary Completion | 2028-04 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
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 2026-02 with a primary completion date of 2028-04.
⚠ 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 PTOC1 cells Injection in the treatment of refractory systemic lupus erythematosus.
Eligibility Criteria
Inclusion Criteria: * Age ≥ 5 years, no gender limitation; * Diagnosed with SLE according to the 2019 EULAR/ACR classification criteria, and still in moderate to severe disease activity despite ≥ 3 months of high dose glucocorticoids(prednisone≥1mg/kg/d or other equivalent amount of other steroid), combined with hydroxychloroquine, and at least 2 Immunosuppressants or biologics (including cyclophosphamide, mycophenolate mofetil, azathioprine, methotrexate, cyclosporin, tacrolimus, sirolimus, leflunomide, telitacicept, belimumab, and rituximab) or intolerant to standard treatments; * SLEDAI-2K score ≥ 8 points; * The functions of vital organs must meet the following requirements: 1. cardiac function: left ventricular ejection fraction (LVEF) ≥ 50%, with no obvious abnormalities on electrocardiogram (ECG); 2. renal function: eGFR ≥ 30 mL/min/1.73m2; 3. hepatic function: AST and ALT ≤ 3.0×ULN, total bilirubin ≤ 2.0×ULN; 4. pulmonary function: no severe pulmonary lesions; blood oxygen saturation ≥ 92% under non-oxygen supplementation conditions. * Meet the criteria 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 infusion; * Participant or his/her guardians agree to participate in the clinical trial and sign the informed consent form 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) diseases: presence of CNS lupus symptoms requiring intervention within 60 days, including epilepsy, confusion, cerebrovascular events, etc; * Congenital heart disease or severe arrhythmia before screening: Including multifocal and frequent supraventricular tachycardia, ventricular tachycardia, etc.; or complicated with moderate to large pericardial effusion, severe myocarditis, etc.; or patients with unstable vital signs who require vasopressors to maintain blood pressure; * Presence of active infections requiring systemic treatment or uncontrolled infections within 3 months prior to screening; * Having received solid organ transplantation or hematopoietic stem cell transplantation within 3 months prior to screening; or having grade 2 or above acute graft-versus-host disease (GVHD) within 2 weeks prior to screening; * Positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with peripheral blood hepatitis B virus (HBV) DNA level exceeding the normal range; positive for hepatitis C virus (HCV) antibody with peripheral blood hepatitis C virus (HCV) RNA level exceeding the normal range; positive for human immunodeficiency virus (HIV) antibody; positive for treponema pallidum antibody; * History of macrophage activation syndrome within 1 month prior to screening (except for those for whom the investigator has determined that safety risks are excluded after treatment); * History of previous CAR-T therapy (except for those for whom the investigator has determined that safety risks are excluded after treatment); * Presence of active pulmonary tuberculosis at the time of screening; * Having received any vaccination within 4 weeks prior to screening; * Positive result of blood pregnancy test; * A confirmed diagnosis of malignant diseases such as tumors prior to screening; * Participation in other clinical trials within 3 months prior to enrollment; * Other circumstances that the investigator deems inappropriate for participation in this study.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07403097 clinical trial?
This trial is open to participants of all sexes, aged 5 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 NCT07403097 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 NCT07403097 currently recruiting?
Yes, NCT07403097 is actively recruiting participants. Contact the research team at zhaoxd530@aliyun.com for enrollment information.
Where is the NCT07403097 trial being conducted?
This trial is being conducted at Chongqing, China.
Who is sponsoring the NCT07403097 clinical trial?
NCT07403097 is sponsored by Chongqing Precision Biotech Co., Ltd. The trial plans to enroll 18 participants.
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