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New treatment option for Systemic Lupus Erythematosus
Official title Study of Ultra-Fast CD19 CAR-T Therapy for Refractory SLE
ClinicalTrials.gov ID: NCT07233642
What this study is testing
What is CD19 CAR-T cells?
CD19 CAR-T cells is an investigational medicine, being studied as a potential treatment for 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
- 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.
- 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 5 and older
You may be able to join if
- Age: ≥ 5 years old, and no gender limitation;
- Diagnosed with SLE according to the 2019 EULAR/ACR SLE classification criteria, and still in moderate to severe disease activity despite ≥3M of high...
- SLEDAI-2K score≥8 points;
- The functions of important organs are basically normal:
- Cardiac function: Left ventricular ejection fraction (LVEF) ≥55% with no obvious abnormality in electrocardiogram;
You likely can't join if
- Central nervous system (CNS) disease: CNS neurolupus requires intervention within 60 days);
- Severe acute nephritis: patients who have accepted or was undergoing renal replacement therapy within 3 months prior to transfusion; or in the...
- Have a history of congenital heart disease or severe arrhythmias (including multisource frequent supraventricular tachycardia, ventricular...
- Uncontrollable infection, or active infection that requires systemic treatment within 3 months prior to screening;
- Received organ transplantation or hematopoietic stem cell transplantation within 3 months prior to screening, or ≥Grade 2 GVHD within 2 weeks prior...
- Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive and peripheral blood hepatitis B virus (HBV) DNA titer greater than...
See the full eligibility criteria
- Age: ≥ 5 years old, and no gender limitation;
- 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...
- SLEDAI-2K score≥8 points;
- The functions of important organs are basically normal:
- Cardiac function: Left ventricular ejection fraction (LVEF) ≥55% with no obvious abnormality in electrocardiogram;
- Renal function: eGFR≥30mL/min/1.73m2;
- Liver function: AST and ALT≤3.0 ULN, total Bilirubin (TBIL) in serum ≤2.0×ULN;
- Lung function: no serious lung lesions, SpO2≥92%;
- Meet the standards of leukapheresis or intravenous blood collection, and no contraindication for leukapheresis;
- Negative pregnancy test for female people of childbearing age, and agree to take effective contraceptive measures the first year after CAR-T infusion;
- Participants or their guardians agrees 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...
- Central nervous system (CNS) disease: CNS neurolupus requires intervention within 60 days);
- Severe acute nephritis: patients who have accepted or was undergoing renal replacement therapy within 3 months prior to transfusion; or in the investgator's opinion, patients who is likely to have significant kidney...
- Have a history of congenital heart disease or severe arrhythmias (including multisource frequent supraventricular tachycardia, ventricular tachycardia, etc.); or combined with moderate to massive pericardial effusion...
- Uncontrollable infection, or active infection that requires systemic treatment within 3 months prior to screening;
- Received organ transplantation or 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...
- Suffered from macrophage activation syndrome(MAS) within 1 month prior to screening (except for those whose safety risks have been ruled out by the researcher after treatment);
- Received CAR-T treatment (except for those whose safety risks have been ruled out by the researchers after treatment);
- Suffered from active pulmonary tuberculosis at screening;
- Received live vaccine within 4 weeks prior to screening;
- Positive in Blood pregnancy test;
- Previous or concurrent malignancy;
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, Zhejiang, 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, 5 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hangzhou, Zhejiang, 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.