Ultra-fast autologous CD19 CAR-T therapy for refractory systemic lupus erythematosus

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-center, investigator-initiated Phase 1 trial uses an ultra-fast manufacturing system to produce autologous CD19-targeted CAR-T cells in minutes for infusion into patients with refractory SLE. Eligible participants are age ≥5 diagnosed by the 2019 EULAR/ACR criteria with SLEDAI-2K ≥8 and persistent disease despite high-dose glucocorticoids plus hydroxychloroquine and at least two DMARDs or who are intolerant to standard treatments, and who have acceptable cardiac, renal, liver, and lung function. After leukapheresis and rapid CAR-T production, participants will receive a CD19 CAR-T infusion and be closely monitored for safety, organ function, disease activity, B cell depletion, and remission duration. The trial prioritizes safety outcomes while collecting early signals of clinical efficacy to guide larger studies.

Why it matters

Who can join: the full rules

Inclusion 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 other steriod), hydroxychloroquine and at least 2 DMARDs(include cyclophosphamide, mycophenolate mofetil, azathioprine, methotrexate, cyclosporin, tacrolimus, sirolimus, leflunomide, telitacicept, Beliumab, and rituximab) or intolerant to standard treatments;
* SLEDAI-2K score≥8 points;
* The functions of important organs are basically normal:

  1. Cardiac function: Left ventricular ejection fraction (LVEF) ≥55% with no obvious abnormality in electrocardiogram;
  2. Renal function: eGFR≥30mL/min/1.73m2;
  3. Liver function: AST and ALT≤3.0 ULN, total Bilirubin (TBIL) in serum ≤2.0×ULN;
  4. 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 subjects 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 participate in the study.

Exclusion Criteria:

* 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 disease within 3 moths of the study which need high dose glucocorticoid (prednisone dose≥1mg/kg/day or equivalent amount of other steriod), cyclophosphamide, or mycophenolate mofetil treatment;
* 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, serious myocarditis, etc; or patients with unstable vital signs who need hypertensive drugs;
* 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 positive and peripheral blood hepatitis C virus (HCV) RNA titer greater than the normal reference value range; or positive for human immunodeficiency virus (HIV) antibodies; or syphilis test positive;
* 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.

Where it's running

• Children's Hospital of Zhejiang University School of Medicine
  Hangzhou, Zhejiang, China Recruiting

Study contacts

• Principal investigator: Jianhua Mao, MD — The Children's Hospital of Zhejiang University School of Medicine
• Study coordinator: Jianhua Mao, MD
• Email: maojh88@zju.edu.cn
• Phone: 13516819071

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• CR-402 treatment for refractory autoimmune disease

  This study tests CRT-402, a CD19-targeted CAR-T therapy, in adults with active, treatment-resistant autoimmune diseases like SLE, systemic sclerosis, and inflammatory myopathy to see if it is safe and capable of helping control disease.

  Recruiting Phase 1/2 Myeloid Therapeutics · Nedlands, Western Australia · NCT07778446

• In Vivo CD19/CD20 CAR T-Cell Therapy for Relapsed or Refractory B-Cell Lymphoma

  This early-phase trial tests a one-time in vivo CAR T-cell therapy (SL1617) for people with relapsed or refractory B-cell lymphoma to see if it is safe and tolerable.

  Recruiting Phase 1 Chinese PLA General Hospital · Beijing · NCT07775508

• In vivo CAR-T therapy Arnovie101 for B cell–mediated autoimmune diseases

  This open-label, single-arm study tests Arnovie101, an mRNA-LNP-based in vivo CAR-T therapy, in adults with relapsed or refractory SLE or AIHA to see if it is safe and how the body handles it.

  Recruiting Early Phase 1 Circunited BioPharma (Shenzhen) Co., Ltd. · Beijing, Beijing Municipality · NCT07629596

• CD19 CAR-T (PTOC1) therapy for refractory systemic lupus erythematosus

  This study will try a fast-made CD19 CAR-T cell treatment called PTOC1 in people aged 5 and older whose lupus has not improved with high-dose steroids and multiple immunosuppressive drugs.

  Recruiting Phase 1 Chongqing Precision Biotech Co., Ltd · Chongqing · NCT07403097

• Ultra-fast autologous CD19 CAR-T therapy for refractory SLE

  This trial will try ultra-fast autologous CD19 CAR-T cells to see if they can control disease in adults with refractory systemic lupus erythematosus.

  Recruiting Phase 1 Chongqing Precision Biotech Co., Ltd · Nanjing, Jiangsu · NCT07331467

• Ultra-fast BCMA/CD70 CAR-T therapy for refractory lupus

  This trial will test ultra-fast BCMA/CD70 CAR-T cell therapy in adults with systemic lupus erythematosus that has not responded to standard treatments.

  Recruiting Phase 1 Chongqing Precision Biotech Co., Ltd · Nanjing, Jiangsu · NCT07318259

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.