Effect of Telitacicept on B Cells in Patients with Lupus

Effect of Telitacicept on Transitional Regulatory B Cells in Patients With Systemic Lupus Erythematosus

This study is testing how the treatment Telitacicept affects certain immune cells in people with lupus to see if it helps improve their condition.

Quick facts

• Study type: Observational
• Enrollment: 50 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Qianfoshan Hospital (Academic / other)
• Drugs / interventions: rituximab, epazumab, prednisone
• Locations: 1 site (Jinan, Shandong)
• Trial ID: NCT06137053 on ClinicalTrials.gov

What this trial studies

This observational study investigates how Telitacicept treatment affects transitional regulatory B lymphocyte subsets and plasma blasts in patients diagnosed with systemic lupus erythematosus (SLE). It aims to measure changes in specific cytokines associated with immune response in SLE patients who are on a stable treatment regimen. Participants must meet established criteria for SLE and have a certain level of disease activity to qualify for the study.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-70 with a confirmed diagnosis of systemic lupus erythematosus and active disease.

Not a fit: Patients with active infections or central nervous system diseases related to lupus may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved understanding and management of systemic lupus erythematosus through targeted therapies.

How similar studies have performed: While this approach is novel in the context of Telitacicept and SLE, similar studies targeting immune modulation in autoimmune diseases have shown promise.

Eligibility criteria

Inclusion Criteria:

1. The diagnosis meets the 2019 EULAR/ACR classification criteria for SLE;
2. Age 18-70 years old;
3. To be on a stable SLE regimen, participants were required to receive standard treatment at least 1 month prior to treatment with a biologic (Telitacicept);
4. Lupus activity Index score (SELENA-SLEDAI) ≥ 8 at screening;
5. Positive anti-nuclear antibody or anti-DSDNA antibody;
6. Combined antiphospholipid syndrome should meet the diagnostic criteria: that is, meet one clinical criterion and one laboratory criterion.

Exclusion Criteria:

1. Active infections (such as shingles, HIV infection, active tuberculosis, etc.) during the screening period;
2. Central nervous system disease (including epilepsy, psychosis, organic encephalopathy syndrome, cerebrovascular accident, encephalitis, central nervous system vasculitis) caused by SLE or not caused by SLE in the last 2 months;
3. Have active hepatitis or a history of severe liver disease;
4. Patients with immune deficiency, uncontrolled severe infection, and active or recurrent digestive ulcer;
5. Pregnant women, breastfeeding women and men or women who have planned to have a baby in the last 12 months;
6. Allergic reaction: history of allergic reaction to human biological products;
7. Those who received live vaccine within the last month;
8. Participants who have participated in any clinical trial within 28 days prior to initial screening/or 5 times the half-life of the study compound (taking an older time);
9. B cell targeted therapy, such as rituximab or epazumab, within one year;
10. Use tumor necrosis factor inhibitors and interleukin-receptor blockers within one year;
11. Patients receiving intravenous gamma globulin (IVIG), prednisone ≥ 100 mg/d for more than 14 days within one month or undergoing plasmapheresis;
12. Psychopaths with depression or suicidal thoughts.

Where this trial is running

Jinan, Shandong

• Yanfeng Hou — Jinan, Shandong, China (Recruiting)

Study contacts

• Study coordinator: Yanfeng Hou, Dr.

Conditions Telitacicept; Systemic Lupus Erythematosus; Therapy