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

NCT07564596 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: TNT119-SLE-102
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Systemic Lupus Erthematosus

Keywords

Lupus; SLE; Biologics; Open-label; Monoclonal; anti-CD19

Outcome Measures

Primary Outcomes (12)

• Incidence of Treatment-Emergent Adverse Events (TEAEs)

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

  Up to week 28

• Incidence of Clinical Laboratory Abnormalities

  Number of participants with clinically significant laboratory abnomalities.

  Up to week 28

• Incidence of dose-limiting toxicities (DLTs)

  Number of incidences of dose-limiting toxicities (DLTs)

  up to 28 weeks

• Change from Baseline in Systolic Blood Pressure

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

  Up to week 28

• Change from Baseline in Diastolic Blood Pressure

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

  up to 28 weeks

• Change from Baseline in Heart Rate

  Mean change from baseline in heart rate (bpm).

  up to 28 weeks

• Change from Baseline in Respiratory Rate

  Mean change from baseline in respiratory rate

  up to 28 weeks

• Change from Baseline in Body Temperature

  Mean change from baseline in body temperature (°C)

  up to 28 weeks

• Change from Baseline in PR Interval

  Mean change from baseline in PR interval (ms)

  up to 28 weeks

• Change from Baseline in QRS Duration

  Mean change from baseline in QRS duration (ms)

  up to 28 weeks

• Change from Baseline in QT Interval

  Mean change from baseline in QT interval (ms)

  up to 28 weeks

• Change from Baseline in QTc Interval

  Mean change from baseline in corrected QT interval (QTc)

  up to 28 weeks

Secondary Outcomes (7)

• Area Under the Curve (AUC)

  Up to week 28

• Terminal Half-Life (T1/2)

  Up to week 28

• Incidence of Anti-Drug Antibodies (ADAs)

  Up to week 28

• ADA Titer Over Time

  Up to week 28

• Change from Baseline in CD20+ B-cell Count

  Up to week 28

Study Arms (4)

Cohort 1: Dose Level A

EXPERIMENTAL

Single IV dose at Day 1 and Day 15

Drug: Budoprutug

Cohort 2: Dose Level B

EXPERIMENTAL

Single IV dose at Day 1 and Day 15

Drug: Budoprutug

Cohort 3: Dose Level C

EXPERIMENTAL

Single IV dose at Day 1 and Day 15

Drug: Budoprutug

Dose Expansion Cohort

EXPERIMENTAL

Single IV dose at Day 1 and Day 15

Drug: Budoprutug

Interventions

Budoprutug DRUG

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

Also known as: TNT119

Cohort 1: Dose Level A; Cohort 2: Dose Level B; Cohort 3: Dose Level C; Dose Expansion Cohort

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Climb Bio, Inc.: lead

Study Sites (1)

Peking University People's Hospital

Beijing, China

Location

Study Officials

• Study Director

  Climb Bio, Inc.

  STUDY DIRECTOR

Central Study Contacts

Climb Bio Study Director

CONTACT

+1 8668572596; clinicaltrials@climbbio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2026
• First Posted: May 4, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: May 4, 2026

Record last verified: 2026-04

Locations

CN (1)