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New treatment option for Systemic Lupus Erythematosus (SLE)
Official title Anti-CD19 Chimeric Antigen Receptor T Cells for Refractory Systemic Lupus Erythematosus
ClinicalTrials.gov ID: NCT06585514
What this study is testing
What is CD19 CAR-T cells?
CD19 CAR-T cells is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for systemic lupus erythematosus (sle).
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 study is to evaluate the safety and efficacy of CD19 CAR T cells in the treatment of Systemic lupus erythematosus (SLE).
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 3 to 65
You may be able to join if
- Male or female, aged 3-65 years.
- Have a diagnosis of SLE and meet the classification criteria of 2019 European League Against Rheumatism (EULAR) and the American College of...
- Positive antinuclear antibody (ANA): ANA at a titer of ≥ 1:80 on Hep-2 cells or equivalent positive test (ever) and/or a positive anti-dsDNA serum...
- Refractory SLE and/or refractory lupus nephritis (LN):
- 4.1 Refractory SLE 4.1.1 Patients received at least 7.5 mg/kg/day of prednisolone to maintain low disease activity or the SLEDAI 2K score ≥8. 4.1.2...
You likely can't join if
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Impaired consciousness or intracranial hypertension:
- Intracranial pressure elevation was above 15 mmHg;
- Organic encephalopathy syndrome, cerebrovascular accident, encephalitis or central nervous system vasculitis, visual impairment, and other brain...
- Symptomatic congestive heart failure or severe cardiac arrhythmia:
- Previously documented left ventricular ejection fraction (LVEF) by echocardiography of \<45% in the 12 months;
See the full eligibility criteria
- Male or female, aged 3-65 years.
- Have a diagnosis of SLE and meet the classification criteria of 2019 European League Against Rheumatism (EULAR) and the American College of Rheumatology (ACR).
- Positive antinuclear antibody (ANA): ANA at a titer of ≥ 1:80 on Hep-2 cells or equivalent positive test (ever) and/or a positive anti-dsDNA serum antibody test (based on ELISA assay, ≥ 30 IU/mL).
- Refractory SLE and/or refractory lupus nephritis (LN):
- 4.1 Refractory SLE 4.1.1 Patients received at least 7.5 mg/kg/day of prednisolone to maintain low disease activity or the SLEDAI 2K score ≥8. 4.1.2 Routine treatment is ineffective or the disease relapses after...
- 4.2 Refractory LN 4.2.1 Diagnosis of SLE based on the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR), Biopsy-proven LN class III, IVa [excluding III (C), IV-S (C) and IV-G (C)]...
- CD19+ on B cells and continuous withdrawal of the immunosuppressive drugs for more than 1 week.
- The blood routine lymphocyte count of the people is \> 1 × 109/L, and there is no cell collection contraindication.
- No severe allergy.
- Eastern Cooperative Oncology Group (ECOG) performance status score 0 to 2.
- Patients are expected to live for at least 90 days.
- people and/or their guardian must understand and sign the informed consent.
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Impaired consciousness or intracranial hypertension:
- Intracranial pressure elevation was above 15 mmHg;
- Organic encephalopathy syndrome, cerebrovascular accident, encephalitis or central nervous system vasculitis, visual impairment, and other brain lesions requiring intervention.
- Symptomatic congestive heart failure or severe cardiac arrhythmia:
- Previously documented left ventricular ejection fraction (LVEF) by echocardiography of \<45% in the 12 months;
- Abnormal electrocardiogram (ECG): left bundle branch block, bifascicular block or any clinically meaningful ECG abnormality;
- Congenital long QT syndrome or prolongation of the QT interval corrected for heart rate (QTcF) ≥ 470 ms. QTcF is calculated using Fridericia's Formula;
- Any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification;
- Unstable or poorly controlled angina pectoris, including the prinzmetal variant of angina pectoris;
- Myocardial infarction within 6 months.
- Manifestations of severe respiratory system failure:
- Hypoxemic respiratory failure: PaO2 \< 60 mmHg, PaCO2 \< 50 mmHg at sea level, resting and breathing air conditions;
- people with pulmonary hypertension (PH): mean pulmonary artery pressure (mPAP) ≥25 mmHg measured by right heart catheterization (RHC);
- people with hypercapnia (PaCO2 ≥ 50mmHg ) and/or ventilatory dysfunction (PH \<7.25 );
- Oxygen inhalation was required to maintain oxygen saturation;
- Acute or chronic respiratory diseases unrelated to SLE, such as acute pneumonia and interstitial lung disease.
- Co-existence with other malignancies.
- Disseminated intravascular coagulation (DIC).
- Sepsis or other uncontrollable infections: active uncontrolled systemic bacterial, viral, fungal, or parasitic infection (except for fungal nail infection) or other clinically significant active disease process.
- Uncontrollable diabetes: after at least 3 months of diet and exercise or similar treatment, fasting blood glucose (FBG) ≥ 8.0 mmol/L, postprandial blood glucose (PBG) ≥ 15 mmol/L, and glycosylated hemoglobin...
- Serious mental illness: alcohol or drug abuse, dementia, or any other condition that would impair the subject's ability to receive the planned treatment or to understand informed consent at the study site.
- Apparent and active intracranial lesions on cranial magnetic resonance imaging (MRI).
- Underwent organ transplantation, excepting SCT.
- Pregnant females or lactation.
- Positive test for infectious hepatitis, acquired immune deficiency syndrome (AIDS) or syphilis.
- No peripheral blood mononuclear cells (PBMC) collection or frozen PBMC for CAR T cell manufacturing.
- eGFR CKD-EPI \< 30 ml/min/1.73m2.
- Patients who are unable to discontinue immunosuppression agents for ≥7 days or whose condition recurs during discontinuation while the risk of serious adverse reactions is assessed by the investigator.
- Any active skin disease that may interfere with the evaluation of SLE, including but not limited to psoriasis, dermatomyositis, systemic sclerosis, non-SLE skin manifestations (e.g., cutaneous vasculopathies...
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
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, 3 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. 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.