Increasing doses of bispecific antibodies for adults with lupus nephritis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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).

Why it matters

Who can join: the full rules

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 it's running

• University of California San Francisco - Zuckerberg San Francisco General
  San Francisco, California, United States Recruiting
• University of Florida
  Gainesville, Florida, United States Recruiting
• Mayo Clinic
  Rochester, Minnesota, United States Recruiting
• Baylor College of Medicine
  Houston, Texas, United States Recruiting
• Centre Hospitalier Universitaire (CHU) Bordeaux
  Bordeaux, New Aquitaine, France Recruiting
• University Hospital Regensburg
  Regensburg, Bavaria, Germany Recruiting

Study contacts

• Study coordinator: Clinical Trials Administrator
• Email: clinicaltrials@regeneron.com
• Phone: 844-734-6643

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.