Increasing doses of bispecific antibodies for adults with lupus nephritis

A Dose Escalation Study Investigating Bispecific Antibody Therapy in Patients With Lupus Nephritis

This research will try different doses of bispecific antibody medicines in adults with lupus nephritis to see if they are safe and tolerable over long-term follow-up.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 90 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: Regeneron Pharmaceuticals (Industry-sponsored)
• Locations: 11 sites (Rochester, Minnesota and 10 other locations)
• Trial ID: NCT06975787 on ClinicalTrials.gov

What this trial studies

This is a phase 1 dose-escalation umbrella study testing multiple bispecific antibodies (including vonsetamig and odronextamab) given for a short treatment period with long-term safety follow-up. Each sub-study enrolls adults with relapsed or refractory systemic lupus erythematosus and class III or IV lupus nephritis to determine safety, tolerability, pharmacokinetics, and immunogenicity. The protocol includes monitoring for adverse events, measuring drug levels in blood, and testing for anti-drug antibodies. The sponsor is Regeneron and sites include Mayo Clinic (Rochester, MN), Baylor College of Medicine (Houston, TX), and University Medical Center Mainz (Mainz, Germany).

Who should consider this trial

Good fit: Adults with SLE and class III or IV lupus nephritis who have relapsed or refractory disease and meet the full protocol eligibility criteria.

Not a fit: Patients with active severe or unstable neuropsychiatric lupus, recent overlap syndromes, catastrophic antiphospholipid syndrome, or other protocol-defined exclusion criteria are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, these bispecific antibodies could provide a new targeted option to reduce kidney inflammation and improve outcomes for some people with lupus nephritis.

How similar studies have performed: Bispecific antibodies are a relatively new approach in autoimmune disease; while related agents have shown promise in early studies in other conditions, their effectiveness specifically in lupus nephritis remains largely unproven.

Eligibility criteria

Key General Inclusion Criteria:

1. Diagnosis of Systemic Lupus Erythematosus (SLE) and LN, as described in the protocol
2. Participant must have refractory or relapsed disease, as described in the protocol

Key General Exclusion Criteria:

1. History of or active severe or unstable lupus-associated neuropsychiatric disease that is likely to require acute or emergent medical treatment or hospitalization
2. Active overlap syndrome with mixed connective tissue disease or systemic sclerosis within 12 months prior to screening or during screening
3. Catastrophic or severe antiphospholipid syndrome within 12 months prior to screening or during screening

NOTE: Other protocol defined inclusion/exclusion criteria apply

Where this trial is running

Rochester, Minnesota and 10 other locations

• Mayo Clinic — Rochester, Minnesota, United States (Recruiting)
• Baylor College of Medicine — Houston, Texas, United States (Recruiting)
• University Medical Center of the Johannes Gutenberg-University Mainz — Mainz, Germany (Recruiting)
• Hallym University Sacred Heart Hospital — Anyang-si, Gyeonggi-do, South Korea (Recruiting)
• Seoul National University Hospital — Seoul, South Korea (Recruiting)
• Samsung Medical Center — Seoul, South Korea (Recruiting)
• Hospital Regional Universitario de Malaga — Málaga, Spain (Recruiting)
• Changhua Christian Hospital — Changhua, Taiwan (Recruiting)
• Taichung General Veterans Hospital — Taichung, Taiwan (Recruiting)
• National Taiwan University Hospital — Taipei, Taiwan (Recruiting)
• Taipei Veterans General Hospital — Taipei, Taiwan (Recruiting)

Study contacts

• Study coordinator: Clinical Trials Administrator

Conditions Lupus Nephritis; Bispecific Antibodies; Double-stranded DNA; LN class III or IV; Systemic Lupus Erythematosus