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Recruiting NCT07564596

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

Phase I / Phase II Interventional Systemic Lupus Erthematosus

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Budoprutug.
Who it may be relevant to
Registry conditions: Systemic Lupus Erthematosus. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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)

Overview

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.

Interventions

  • Drug Budoprutug
    Single IV dose of study product on Day 1 and Day 15

Primary outcome measures

  • Incidence of Treatment-Emergent Adverse Events (TEAEs) [Time frame: Up to week 28]
  • Incidence of Clinical Laboratory Abnormalities [Time frame: Up to week 28]
  • Incidence of dose-limiting toxicities (DLTs) [Time frame: up to 28 weeks]
  • Change from Baseline in Systolic Blood Pressure [Time frame: Up to week 28]
  • Change from Baseline in Diastolic Blood Pressure [Time frame: up to 28 weeks]
  • Change from Baseline in Heart Rate [Time frame: up to 28 weeks]
  • Change from Baseline in Respiratory Rate [Time frame: up to 28 weeks]
  • Change from Baseline in Body Temperature [Time frame: up to 28 weeks]
  • Change from Baseline in PR Interval [Time frame: up to 28 weeks]
  • Change from Baseline in QRS Duration [Time frame: up to 28 weeks]
Secondary outcome measures (7)
  • Area Under the Curve (AUC) [Time frame: Up to week 28]
  • Terminal Half-Life (T1/2) [Time frame: Up to week 28]
  • Incidence of Anti-Drug Antibodies (ADAs) [Time frame: Up to week 28]
  • ADA Titer Over Time [Time frame: Up to week 28]
  • Change from Baseline in CD20+ B-cell Count [Time frame: Up to week 28]
  • Change from Baseline in SLEDAI-2K Score [Time frame: up to 28 weeks]
  • Change from Baseline in Urine Protein Creatinine Ratio (UPCR) [Time frame: up to 28 weeks]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

China · 2 centers
  • Mianyang Central Hospital — Mianyang
  • Peking University People's Hospital — Beijing

Identifiers

NCT: NCT07564596 · TNT119-SLE-102

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗