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New treatment option for Refractory Systemic Lupus Erythematosus
Official title CD19 CAR T-Cell Therapy for Refractory Systemic Lupus Erythematosus
ClinicalTrials.gov ID: NCT07432334
What this study is testing
What is Autologous CD19-Targeted CAR-T Cells?
Autologous CD19-Targeted CAR-T Cells is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for refractory systemic lupus erythematosus.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this Phase I clinical trial is to evaluate the safety and tolerability of autologous CD19-targeted chimeric antigen receptor T-cell (CAR-T) therapy in adults with refractory systemic lupus erythematosus who have demonstrated inadequate response to standard-of-care immunosuppressive treatments. The primary questions this study aims to address are: What is the incidence, nature, and severity of treatment-emergent adverse events following CD19 CAR-T cell infusion?
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 16 to 55
You may be able to join if
- 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...
- Positive antinuclear antibody (ANA ≥ 1:80) OR positive anti-dsDNA OR positive anti-Sm antibody at screening or documented in medical history...
- Persistent active lupus nephritis after two induction regimens, including intravenous cyclophosphamide and mycophenolate mofetil administered for ≥ 6...
You likely can't join if
- 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...
- 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
See the full eligibility 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...
- 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...
- 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)
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Hanoi, Vietnam
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 16 years to 55 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hanoi, Vietnam. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.