Dose Escalation Study With Bispecific Antibodies in Adult Participants With Lupus Nephritis

RecruitingPhase 1

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

Who can join

Ages 18 to 60 · All sexes

Full 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

About the study

This study is researching a particular group of experimental drugs administered for a short period in the treatment of participants with Lupus Nephritis (LN).

The main aim of the current study is to see how safe and tolerable the study drugs are in a long-term follow-up.

This is a main study, called an umbrella study, which includes several independent smaller sub-studies. Each of these smaller main sub-studies tests different drugs at the same time, all aimed at treating LN.

The study is looking at several other research questions, including:

* What side effects may happen from taking the study drug * How much study drug is in the blood at different times * Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)

What is being tested

Vonsetamig (drug)
Odronextamab (drug)

Sponsor: Regeneron Pharmaceuticals · Participants: 90 · Started: Dec 22, 2025

Contact the study team

Clinical Trials Administrator · Phone: 844-734-6643

Official record on ClinicalTrials.gov — NCT06975787

Locations in the U.S.

California	University of California San Francisco - Zuckerberg San Francisco General, San Francisco
Minnesota	Mayo Clinic, Rochester
Texas	Baylor College of Medicine, Houston

Conditions

From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.