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

Study of Ultra-Fast Autologous CD19-Targeted Chimeric Antigen Receptor T (CAR- T) Therapy for Refractory Systemic Lupus Erythematosus

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.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Chongqing Precision Biotech Co., Ltd (Industry-sponsored)
• Drugs / interventions: beliumab, rituximab, CAR-T, methotrexate, cyclophosphamide, prednisone, belimumab
• Locations: 1 site (Nanjing, Jiangsu)
• Trial ID: NCT07331467 on ClinicalTrials.gov

What this trial studies

This is a Phase 1, single-site interventional trial testing an ultra-fast autologous CD19-targeted CAR-T product produced with a rapid manufacturing system. Eligible adults with moderate to severe refractory SLE will undergo leukapheresis for T cell collection, rapid CAR-T preparation, and infusion, with close follow-up for safety and preliminary signs of clinical benefit. Primary outcomes focus on safety and tolerability, with secondary measures tracking disease activity (including SLEDAI-2K) and medication tapering. The protocol targets patients who have failed high-dose glucocorticoids and at least two disease-modifying agents.

Who should consider this trial

Good fit: Adults (≥18) with SLE by 2019 EULAR/ACR criteria who have moderate to severe refractory disease (SLEDAI-2K ≥8) despite high-dose steroids and at least two DMARDs, who are eligible for leukapheresis and agree to contraception are the intended participants.

Not a fit: Patients with mild or well-controlled SLE, those unable to undergo leukapheresis, pregnant individuals, or those with uncontrolled active infections are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, this approach could deplete pathogenic B cells and produce durable remission, potentially reducing or stopping long-term immunosuppression for some patients.

How similar studies have performed: Early clinical reports since 2019 have shown promising responses using CD19-targeted CAR-T in autoimmune diseases, including case series in SLE, but larger controlled data remain limited.

Eligibility criteria

Inclusion Criteria:

* Age ≥ 18 years old;
* 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), and/or 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;
* 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 until one year after CAR-T infusion;
* Participant or his/her guardians agree 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 30 days;
* Have a history of congenital heart disease or acute myocardial infarction within 6 months prior to screening or severe arrhythmias (including multisource frequent supraventricular tachycardia, ventricular tachycardia, etc.); or NYHA classification class IV; or combined with moderate to massive pericardial effusion, serious myocarditis, etc; or patient with unstable vital signs who need hypertensive drugs;
* The functions of important organs meet one of the following conditions: (1)renal function: eGFR\<30mL/min/1.73m2 or require renal replacement therapy; (2)liver function: AST and ALT\>3.0 ULN, total Bilirubin (TBIL) in serum \>2.0×ULN; (3)lung function: SpO2\<92% with no oxygen inhalation;
* Uncontrollable infection or active infection that requires systemic treatment within 3 months prior to screening;
* Received 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 active pulmonary tuberculosis at screening;
* Received live vaccine within 4 weeks prior to screening;
* Positive in blood pregnancy test;
* Suffered from malignant disease such as tumors (excluding tumors without active lesions and ending treatment for more than 5 years, as well as fully treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, thyroid cancer after radical resection, ductal carcinoma in situ after radical resection);
* 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 this trial is running

Nanjing, Jiangsu

• Affiliated Drum Tower Hospital, Medical School of Nanjing University — Nanjing, Jiangsu, China (Recruiting)

Study contacts

• Study coordinator: Lingyun Sun

Conditions Systemic Lupus Erythematosus; CD19; CAR-T