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Budoprutug infusion for adults with active, seropositive lupus

A Phase 1b Open-Label, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Budoprutug (TNT119) in Adult Subjects With Systemic Lupus Erythematosus (SLE)

Phase 1 Interventional Climb Bio, Inc. · NCT07011043

This trial will try one IV infusion of budoprutug to see if it is safe and how it affects B cells and symptoms in adults 18–65 with active, seropositive lupus who haven't responded to standard treatments.

Quick facts

PhasePhase 1
Study typeInterventional
Enrollment30 (estimated)
Ages18 Years to 65 Years
SexAll
SponsorClimb Bio, Inc. Industry-sponsored
Locations18 sites (Allen, Texas and 17 other locations)
Trial IDNCT07011043 on ClinicalTrials.gov

What this trial studies

This is a Phase 1b, open-label, single-ascending-dose trial testing a single intravenous infusion of budoprutug in adults with active, seropositive systemic lupus erythematosus who have had an inadequate response to at least two prior therapies. The primary focus is safety and tolerability, with serial pharmacokinetic and pharmacodynamic measurements following dosing. Pharmacodynamics will be measured by changes in circulating B cells and immunoglobulin levels over time, and investigators will also look for early signs of clinical benefit. Dose-escalation cohorts will help characterize tolerability across increasing doses.

Who should consider this trial

Good fit: Adults aged 18–65 with active, seropositive SLE (SLEDAI-2K ≥8) who have had an inadequate response to at least two therapies, including an oral immunosuppressive or biologic, are the intended candidates.

Not a fit: People with active neuropsychiatric lupus, other inflammatory autoimmune diseases requiring immunosuppression, active or recent serious infections, or those outside the 18–65 age range are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, budoprutug could lower B cells and autoantibodies that drive lupus activity and potentially reduce symptoms and flares.

How similar studies have performed: B-cell–depleting therapies such as anti-CD20 antibodies have shown benefit for some lupus patients, but CD19-targeted monoclonal antibodies are less well studied and remain experimental in SLE.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Aged 18 to 65 years at the time of consent.
2. Diagnosis of SLE according to the 2019 European League Against. Rheumatism and the American College of Rheumatology (ACR) classification criteria.
3. Active, seropositive disease, with SLEDAI 2K \>=8.
4. Inadequate response to at least 2 therapeutic interventions, including at least one oral immunosuppressive or biologic standard-of care therapy.

Exclusion Criteria:

1. Active neuropsychiatric SLE.
2. History of inflammatory or autoimmune diseases including, but not limited to, rheumatoid arthritis, scleroderma, myositis, vasculitis, inflammatory bowel disease, or other conditions that require immune suppressive therapy. Subjects with stable concurrent Sjogren's, asthma, or autoimmune thyroid disease may be considered for participation.
3. Active systemic infection or history of chronic, recurrent, latent, or recent serious infections.

Where this trial is running

Allen, Texas and 17 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Systemic Lupus ErythematosusLupusSLEBiologicsOpen-labelMonoclonalAnti-CD19
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.