Anti-CD19 CAR-T cell therapy for people with lupus that has not responded to treatment
Studies anti-CD19 CAR-T cells in adults with systemic lupus erythematosus that resists treatment.
Plain-language title generated from the registry record
Registry title: Anti-CD19 CAR-T Cell Therapy for Patients With Refractory Systemic Lupus Erythematosus
Key facts
- Where
- Lyasny, BelarusSee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with systemic lupus erythematosus (SLE) that is still active despite earlier treatment. It tests anti-CD19 CAR-T cell therapy.
- Age
- 18 to 70 years
- Sex
- All sexes can join.
- Disease stage
- Confirmed SLE (2019 EULAR/ACR criteria), subacute or acute. Active disease (SELENA-SLEDAI score of 6 or more) and/or needing prednisolone above 7.5 mg/day to keep the disease quiet.
- Earlier treatment
- Two or more earlier treatments, including mycophenolate mofetil or cyclophosphamide, or side effects/intolerance to these drugs. No change in therapy in the 90 days before CAR-T treatment.
Main reasons for not taking part
- Needing kidney replacement therapy
- Active hepatitis B or C, or HIV infection
- Uncontrolled life-threatening infection
- Current or past cancer, with a few exceptions
- Pregnant or breastfeeding women
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Source: NCT07720310, who can take part
Where in Belarus
- NN Alexandrov National Cancer Centre of BelarusLyasny, BelarusNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- N.N. Alexandrov National Cancer Centre
- Trial code
- NCT07720310
- Record updated
- 22 July 2026
- Original description
Systemic lupus erythematosus (SLE) is a chronic autoimmune disease characterized by B-cell dysfunction leading to the production of autoantibodies that play a key role in the onset and progression of the disease. In the treatment of SLE today, glucocorticosteroid hormones, cytostatics (azathioprine, cyclophosphamide, mycophenolate mofetil, hydroxychloroquine, etc.), and biological therapy (rituximab, belimumab) are widely used. However, this therapy has limitations: firstly, it does not always control the autoimmune process and, secondly, it has side effects. Recent global data on the use of CAR T cells in patients with SLE show promising results, including rapid and durable remission, without the need for disease-modifying drugs and glucocorticoids. The use of the so-called academic CAR-T cell products can improve availability and affordability of this therapy option. The aim of this clinical study is to evaluate the efficacy and safety of academic CAR-T cells in refractory SLE patients.Read full original descriptionShow less
Anti-CD19 CAR-T Cell Therapy for Patients With Refractory Systemic Lupus Erythematosus
Systemic lupus erythematosus (SLE) is a chronic autoimmune disease characterized by B-cell dysfunction leading to the production of autoantibodies that play a key role in the onset and progression of the disease. In the treatment of SLE today, glucocorticosteroid hormones, cytostatics (azathioprine, cyclophosphamide, mycophenolate mofetil, hydroxychloroquine, etc.), and biological therapy (rituximab, belimumab) are widely used. However, this therapy has limitations: firstly, it does not always control the autoimmune process and, secondly, it has side effects. Recent global data on the use of CAR T cells in patients with SLE show promising results, including rapid and durable remission, without the need for disease-modifying drugs and glucocorticoids. The use of the so-called academic CAR-T cell products can improve availability and affordability of this therapy option. The aim of this clinical study is to evaluate the efficacy and safety of academic CAR-T cells in refractory SLE patients.
Inclusion: A confirmed diagnosis of SLE according to the 2019 EULAR/ACR criteria; Subacute or acute SLE; SLE activity according to the SELENA-SLEDAI disease activity index screening score ≥6 and/or the requirement for prednisolone (or equivalent doses of methylprednisolone) at a dose greater than 7.5 mg/day (6 mg/day for methylprednisolone) to maintain lower disease activity; A history of two or more prior therapies (one of the drugs mycophenolate mofetil or cyclophosphamide, or the development of side effects/intolerance to these drugs); Patients aged 18 years or older; A medical consultation on the need for this treatment method using cell therapy; Written informed consent from the patient for treatment; Patient compliance with the treatment protocol; Adequate organ function.
Exclusion: Any change in therapy within 90 days prior to the planned administration of CAR-T cell therapy; Patient requiring renal replacement therapy; Unstable angina and/or myocardial infarction within 6 months prior to screening; Previous or concomitant malignancy with the exception of:; basal cell or squamous cell carcinoma (adequate wound healing is required before study entry); In situ carcinoma of the cervix or breast, without evidence of recurrence for at least 3 years prior to study entry; A primary malignant tumor that has been completely resected and in complete remission for ≥ 5 years; Active hepatitis B or active hepatitis C (HCV RNA positive); HIV-infected patients; Uncontrolled acute life-threatening bacterial, viral, or fungal infection (e.g., positive blood culture ≤ 72 hours before infusion); Cardiac arrhythmia not controlled by medical therapy; Patients with active neurological autoimmune or inflammatory disorders (e.g., Guillain-Barré syndrome, amyotrophic lateral sclerosis); Pregnant and lactating women; Intolerance to the excipients of the cell product; The presence of any primary immunodeficiency; Socioeconomic or geographic circumstances that cannot guarantee adequate compliance with the protocol requirements for treatment and follow-up; -.