Using Belimumab and T-cell Therapy for Systemic Lupus Erythematosus

Sequential Belimumab Followed by T-cell Based Therapy in the Treatment of Systemic Lupus Erythematosus (SUBTLE) - a Preliminary Proof-of-concept Mechanistic Study

This study is testing if a medication called Belimumab can improve the immune response in adults with active Systemic Lupus Erythematosus by looking at how it affects T cells.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 21 Years to 70 Years
• Sex: All
• Sponsor: National University Hospital, Singapore (Academic / other)
• Drugs / interventions: cyclophosphamide, Belimumab
• Locations: 1 site (SIngapore)
• Trial ID: NCT04447053 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effects of Belimumab, a monoclonal antibody that targets B cells, on T cells in patients with Systemic Lupus Erythematosus (SLE). The study will enroll 80 adult participants with active SLE, assessing the impact of Belimumab on their immune response. Participants will be monitored for changes in disease activity and immune cell function. The trial aims to enhance understanding of SLE management by exploring the interplay between B and T cells in this condition.

Who should consider this trial

Good fit: Ideal candidates are adults aged 21 and older with active SLE who meet specific classification criteria.

Not a fit: Patients with severe active nephritis may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment strategies for patients with Systemic Lupus Erythematosus.

How similar studies have performed: Other studies have shown promise in targeting B cells for SLE treatment, but the specific combination with T-cell therapy is novel.

Eligibility criteria

Inclusion Criteria:

1. Age ≥ 21
2. Able to understand the details of the trial and willing to give written informed consent and comply with the requirements of the study protocol.
3. Patients who fulfill the classification criteria (SLICC 2012 or ACR 1997) for SLE and have active disease (SELENA-SLEDAI ≥ 6).
4. Patients whose sera are positive for ANA (titre ≥ 1:80) or anti-dsDNA (\>100U/L based on NUH standard laboratory cut-off).
5. Patients who are on stable dose of prednisolone (0-40mg/day) and/or non-steroidal anti-inflammatory, antimalarial or immunosuppressive drugs for at least 30 days before first study dose.
6. Females of child-bearing potential and non-sterilized males with female partners of child-bearing potential may participate this trial only if they use a reliable means of contraception.
7. Females of child-bearing potential must have a negative serum pregnancy test within three weeks prior to baseline.

Exclusion Criteria:

1. They have severe active nephritis and/or active CNS lupus and/or other autoimmune diseases e.g. RA, mixed connective tissue disease, scleroderma, dermatomyositis and polymyositis.
2. They are pregnant.
3. They have had previous treatment with any B-cell and T-cell targeted biologic therapy, intravenous (IV) cyclophosphamide within 6 months of enrolment, intravenous immunoglobulins or prednisolone (\>100mg/day) within 3 months.

Where this trial is running

SIngapore

• National University Hospital — SIngapore, Singapore (Recruiting)

Study contacts

• Principal investigator: Anselm Mak — National University Hospital, Singapore
• Study coordinator: Anselm Mak

Conditions Systemic Lupus Erythematosus