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System Lupus Erythematosus(SLE)NCT07720310

Anti-CD19 CAR-T Cell Therapy for Patients With Refractory Systemic Lupus Erythematosus

An observational study of System Lupus Erythematosus(SLE), run by N.N. Alexandrov National Cancer Centre at 1 site in Belarus.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
System Lupus Erythematosus(SLE)
What is being tested?
CAR T cells chimeric antigen receptor cells
How many people
12 participants
Where
1 siteBelarus
Study dates
9 Mar 2026to Jun 2030
How long will I take part?
2 Years
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with refractory SLE treated in N.N. Alexandrov National Cancer Center

Who may be able to join

  • 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.
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  • Written informed consent from the patient for treatment.
  • Patient compliance with the treatment protocol.
  • Adequate organ function.

Who cannot join

  • Any change in therapy within 90 days prior to the planned administration of CAR-T cell therapy.
  • Patient requiring renal replacement therapy.
  • 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).
  • Unstable angina and/or myocardial infarction within 6 months prior to screening.
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  • 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.
  • Pregnant and lactating women.
  • Intolerance to the excipients of the cell product.
  • Cardiac arrhythmia not controlled by medical therapy.
  • Patients with active neurological autoimmune or inflammatory disorders (e.g., Guillain-Barré syndrome, amyotrophic lateral sclerosis).
  • The presence of any primary immunodeficiency.
  • Socioeconomic or geographic circumstances that cannot guarantee adequate compliance with the protocol requirements for treatment and follow-up.
  • -

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Belarus1 site

  • NN Alexandrov National Cancer Centre of Belarus

    Lyasny, Minsk Oblast, 223040

Other trials in Belarus

About this study

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.

Being tested
CAR T cells chimeric antigen receptor cells
Keywords
academic CAR-T cell product refractory, refractory SLE, efficacy, safety
Medical subject headings
Lupus Erythematosus, Systemic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CAR T cells chimeric antigen receptor cellsBiological

    academical CAR-T product was manufactured using lentiviral vector encoding anti-CD19 CAR.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. SELENA-SLEDAI activity index assessment and serologic remission (defined as normal level of primary (dsDNA and/or antiSm) and antiphospholipid antibodies (lupus anticoagulant (LA), AT to cardiolipinanti-dsDNA and normal complement C3 and C4 levels)

    SELENA-SLEDAI (Safety of Estrogens in Lupus Erythematosus National Assessment - Systemic Lupus Erythematosus Disease Activity Index)

    Score Interpretation:

    0 points: Remission / no activity 1-4 points: Low activity 5-10 points: Moderate activity > 10 points: High activity (Scores ≥ 6 typically indicate active disease requiring treatment)

    Measured: 36 months after CAR-T cells infusion

Secondary outcomes (1)

  1. Evaluation of CAR T-Cell-Related Toxicities

    Evaluation of Cytokine Release Syndrom (CRS) according NCCN guidelines version 2.2026.

    Immune Effector cell-associated Neurotoxicity Syndrom (ICANS) accordin NCCN guidelines version 2.2026.

    Measured: Start from 0 day up to 30 days after CAR-T cells infusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jul 2026
  2. Study start9 Mar 2026
  3. Primary completionJun 2028 (estimated)
  4. Study completionJun 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
12 participants (estimated)
Target duration
2 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT07720310
Sponsor's protocol ID
20251677
Status last verified
Jul 2026
First submitted
13 Jul 2026
Last updated
22 Jul 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of System Lupus Erythematosus(SLE), run by N.N. Alexandrov National Cancer Centre at 1 site in Belarus.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belarus. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

SELENA-SLEDAI activity index assessment and serologic remission (defined as normal level of primary (dsDNA and/or antiSm) and antiphospholipid antibodies (lupus anticoagulant (LA), AT to cardiolipinanti-dsDNA and normal complement C3 and C4 levels) (time frame: 36 months after CAR-T cells infusion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07720310.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.

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