Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-26 @ 3:19 PM
NCT ID:
NCT07432334
Eligibility Criteria:
Inclusion Criteria:
* Age 16 to 55 years, male or female
* Diagnosis of systemic lupus erythematosus (SLE) according to the 2019 EULAR/ACR classification criteria with a total score ≥ 10
* SLEDAI-2K score ≥ 8 at screening (with at least 4 points derived from laboratory parameters; excluding points attributable to central nervous system involvement)
* Positive antinuclear antibody (ANA ≥ 1:80) OR positive anti-dsDNA OR positive anti-Sm antibody at screening or documented in medical history
Refractory systemic lupus erythematosus or refractory lupus nephritis defined as one of the following:
Refractory SLE:
\- Failure to achieve adequate response, partial response, or stable disease control after ≥ 6 months of standard-of-care therapy (documented compliance). Standard therapy includes corticosteroids plus hydroxychloroquine and at least two of the following: calcineurin inhibitors, cyclophosphamide, mycophenolate mofetil, azathioprine, or B-cell-targeted therapy (e.g., rituximab, belimumab).
Refractory Lupus Nephritis:
* Persistent active lupus nephritis after two induction regimens, including intravenous cyclophosphamide and mycophenolate mofetil administered for ≥ 6 months (with or without calcineurin inhibitors, rituximab, or belimumab), AND:
* Histopathologic confirmation of Class III or Class IV lupus nephritis, with or without Class V (ISN/RPS 2003 classification); isolated Class V is excluded
* Proteinuria \> 1 g/24 hours OR urine protein-to-creatinine ratio \> 1 mg/mg
* Adequate organ function:
* ALT ≤ 5 × upper limit of normal; total bilirubin ≤ 34 μmol/L (≤ 2.0 mg/dL)
* Pulmonary function: FVC ≥ 60% predicted OR FEV1 ≥ 60% predicted
* Cardiac function: LVEF ≥ 50%, no uncontrolled arrhythmia, no intracardiac thrombus, no heart failure
* Adequate hematologic parameters:
* Absolute neutrophil count ≥ 0.8 × 10⁹/L (without growth factor support)
* Absolute lymphocyte count ≥ 0.3 × 10⁹/L
* Platelet count ≥ 50 × 10⁹/L
* Hemoglobin ≥ 80 g/L (≥ 8.0 g/dL)
* Ability to provide written informed consent
* Agreement to use effective contraception during the study period (for participants of reproductive potential)
Exclusion Criteria:
* History of significant neurologic disorders (e.g., traumatic brain injury, seizure disorder, hemorrhagic conditions, impaired consciousness)
* Significant cardiovascular disease within 3 months prior to screening (e.g., uncontrolled hypertension, NYHA Class III-IV heart failure, severe arrhythmia, unstable angina, myocardial infarction)
* Prior kidney transplantation
* Severe asthma requiring long-term treatment or respiratory failure
* Severe hemolytic anemia requiring transfusion at intervals ≤ 7 days
* Active viral infections (e.g., hepatitis B or C, HIV, tuberculosis, malaria, syphilis, CMV, EBV) or other life-threatening infectious diseases
* Active bacterial infection confirmed by clinical evaluation, imaging, or laboratory testing
* Use of the following prior to leukapheresis:
* Anti-CD20 therapy, cyclophosphamide, live or attenuated vaccines within 1 month
* Systemic corticosteroids \> 10 mg/day (prednisone equivalent), T-cell-targeted therapy (e.g., mycophenolate mofetil, calcineurin inhibitors), immunosuppressive agents, or antimalarial agents within 7 days
* Prior anti-CD19 therapy
* Prior T-cell-based cellular therapy or gene therapy, including CAR-T therapy
* Current or prior malignancy
* Known hypersensitivity to study-related agents
* Pregnant or breastfeeding women
* Active antiphospholipid syndrome (stable antiphospholipid antibody positivity without active APS is permitted)
* Participation in another clinical trial at the time of screening
* Any condition that, in the investigator's judgment, would interfere with protocol compliance or study participation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Maximum Age:
55 Years
Study:
NCT07432334
Study Brief:
Protocol Section:
NCT07432334