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NCT Number: NCT07564596

A Phase 1b/2a Study of Budoprutug in Systemic Lupus Erythematosus (SLE)

Budoprutug is a humanized, immunoglobulin (Ig) G1 monoclonal antibody that selectively binds to CD19 and is projected to deplete targeted cells through antibody-dependent cellular cytotoxicity. This Phase 1b/2a, open-label study will evaluate budoprutug in ascending dose cohorts of patients aged 18 years and above with active, seropositive SLE and inadequate response to standard therapy. The study will also assess the pharmacokinetics, pharmacodynamics and early indications of efficacy of budoprutug in SLE, where pharmacodynamics will be evaluated as the change in the number of B cells and immunoglobulins (antibodies) in the blood over time. Budoprutug will be administered as two (2) IV infusions 14 days apart in ascending dose cohorts.

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Key information

Conditions

Systemic Lupus Erthematosus

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Peking University People's Hospital

Beijing, China

Location contact

Climb Bio Investigative Site

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged 18 to 65 years at the time of consent.
  • Diagnosis of SLE according to the 2019 European League Against. Rheumatism and the American College of Rheumatology (ACR) classification criteria.
  • Active, seropositive disease, with SLEDAI 2K >=6 at screening
  • Inadequate response to at least one therapeutic intervention

Exclusion criteria

  • Active neuropsychiatric SLE.
  • Active lupus nephritis type III or IV that is expected to require induction therapy during the study or recently treated with induction therapy within 12 weeks.
  • Prior diagnosis of, or fulfills diagnostic criteria for, other autoimmune or inflammatory disease that may confound clinical assessments or increase subject risk in the study
  • Active systemic infection or history of chronic, recurrent, latent, or recent serious infections.

Treatment and study plan

Budoprutug

Drug

Single IV dose of study product on Day 1 and Day 15

Other names: TNT119

Primary outcomes

  1. Incidence of Treatment-Emergent Adverse Events (TEAEs)

    Time frame: Up to week 28

    Number of participants experiencing TEAEs, graded per NCI CTCAE v6.0.

  2. Incidence of Clinical Laboratory Abnormalities

    Time frame: Up to week 28

    Number of participants with clinically significant laboratory abnomalities.

  3. Incidence of dose-limiting toxicities (DLTs)

    Time frame: up to 28 weeks

    Number of incidences of dose-limiting toxicities (DLTs)

  4. Change from Baseline in Systolic Blood Pressure

    Time frame: Up to week 28

    Mean change from baseline in diastolic blood pressure (mmHg).

  5. Change from Baseline in Diastolic Blood Pressure

    Time frame: up to 28 weeks

    Mean change from baseline in systolic blood pressure (mmHg).

  6. Change from Baseline in Heart Rate

    Time frame: up to 28 weeks

    Mean change from baseline in heart rate (bpm).

  7. Change from Baseline in Respiratory Rate

    Time frame: up to 28 weeks

    Mean change from baseline in respiratory rate

  8. Change from Baseline in Body Temperature

    Time frame: up to 28 weeks

    Mean change from baseline in body temperature (°C)

  9. Change from Baseline in PR Interval

    Time frame: up to 28 weeks

    Mean change from baseline in PR interval (ms)

  10. Change from Baseline in QRS Duration

    Time frame: up to 28 weeks

    Mean change from baseline in QRS duration (ms)

  11. Change from Baseline in QT Interval

    Time frame: up to 28 weeks

    Mean change from baseline in QT interval (ms)

  12. Change from Baseline in QTc Interval

    Time frame: up to 28 weeks

    Mean change from baseline in corrected QT interval (QTc)

Secondary outcomes

  1. Area Under the Curve (AUC)

    Time frame: Up to week 28

    Measurement of the area under the drug concentration-time curve

  2. Terminal Half-Life (T1/2)

    Time frame: Up to week 28

    Measurement of the terminal half-life in days

  3. Incidence of Anti-Drug Antibodies (ADAs)

    Time frame: Up to week 28

    Number of participants with detectable ADAs.

  4. ADA Titer Over Time

    Time frame: Up to week 28

    Measurement of ADA titer over time

  5. Change from Baseline in CD20+ B-cell Count

    Time frame: Up to week 28

    Change in absolute peripheral B-cell count

  6. Change from Baseline in SLEDAI-2K Score

    Time frame: up to 28 weeks

    Measurement of change in SLEDAI-2K score from baseline

  7. Change from Baseline in Urine Protein Creatinine Ratio (UPCR)

    Time frame: up to 28 weeks

    Measurement of change in UPCR from baseline

Study contacts

Contact information is provided by the study sponsor or research team.

Climb Bio Study Director

CONTACT

[email protected]

+1 8668572596

Sponsors and collaborators

Lead sponsor

Climb Bio, Inc.

Industry

Registry information

Official study title

A Phase 1b/2a Open-Label, Dose-Escalation and Dose-Expansion Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Budoprutug (TNT119) in Adult Subjects With Systemic Lupus Erythematosus (SLE)

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 4, 2026
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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