NCT07720310Enrolling by invitation
Anti-CD19 CAR-T Cell Therapy for Patients With Refractory Systemic Lupus Erythematosus
Source: ClinicalTrials.gov · Last updated 22 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Study type
- Observational
- Enrollment
- 12 (estimated)
- First submitted
- 13 Jul 2026
- Start date
- 9 Mar 2026
- Primary completion date
- Jun 2028
- Lead sponsor
- N.N. Alexandrov National Cancer Centre
- Diseases
- Lupus (SLE)
- NCT number
- NCT07720310
What you commit to
- Study type: Observational
- Planned participants: 12
- From 9 Mar 2026 to the primary completion date, Jun 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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).
Other
- 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.
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Who the study is looking for
- 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.
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| NN Alexandrov National Cancer Centre of Belarus Coordinator of this site? Confirm its status | Lyasny | Belarus | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.