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Systemic Lupus ErthematosusPhase 1/2NCT07564596

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

A Phase 1/2 study testing Budoprutug in people with Systemic Lupus Erthematosus, run by Climb Bio, Inc. at 10 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Systemic Lupus Erthematosus
What is being tested?
Budoprutug
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
10 sitesChina
Study dates
30 Jun 2026to Sep 2027
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

10 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Climb Bio Study Director contact

+1 8668572596

clinicaltrials@climbbio.com

10 sites in 1 country

China10 sites, 9 recruiting

  • Baoji Central Hospital

    Baoji

    Climb Bio Investigate Site 12, clinicaltrials@climbbio.com

    Recruiting

  • Peking University People's Hospital

    Beijing

    Climb Bio Investigative Site 1, clinicaltrials@climbbio.com

    Recruiting

  • The First Affiliated Hospital of Bengbu Medical College

    Bengbu

    Climb Bio Investigative Site 7, clinicaltrials@climbbio.com

    Not yet recruiting

  • Xiangya Second Hospital of Central South University

    Changsha

    Climb Bio Investigative Site 13, clinicaltrials@climbbio.com

    Not yet recruiting

  • The First Affiliated Hospital of the University of Science

    Hefei

    Climb Bio Investigative Site 4, clinicaltrials@climbbio.com

    Not yet recruiting

  • Mianyang Central Hospital

    Mianyang, Sichuan, 621000

    Active, not recruiting

  • The First Affiliated Hospital of Nanchang

    Nanchang

    Climb Bio Investigative Site 15, clinicaltrials@climbbio.com

    Not yet recruiting

  • The Second Affiliated Hospital of Soochow University

    Suzhou

    Climb Bio Investigative Site 3, clinicaltrials@climbbio.com

    Not yet recruiting

  • Shanxi Bethune Hospital

    Taiyuan

    Climb Bio Investigative Site 5, clinicaltrials@climbbio.com

    Recruiting

  • Zaozhuang Municipal Hospital

    Zaozhuang

    Climb Bio Investigative Site 11, clinicaltrials@climbbio.com

    Not yet recruiting

Other trials in China

About this study

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)

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.

Being tested
Budoprutug
Keywords
Lupus, SLE, Biologics, Open-label, Monoclonal, anti-CD19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BudoprutugDrug

    Also called TNT119

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

Study groups in NCT07564596
Study groupRoleWhat they receive
Cohort 1: Dose Level AExperimentalSingle IV dose at Day 1 and Day 15
Receives: Drug: Budoprutug
Cohort 2: Dose Level BExperimentalSingle IV dose at Day 1 and Day 15
Receives: Drug: Budoprutug
Cohort 3: Dose Level CExperimentalSingle IV dose at Day 1 and Day 15
Receives: Drug: Budoprutug
Dose Expansion CohortExperimentalSingle IV dose at Day 1 and Day 15
Receives: Drug: Budoprutug

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

    Measured: Up to week 28

  2. Incidence of Clinical Laboratory Abnormalities

    Number of participants with clinically significant laboratory abnomalities.

    Measured: Up to week 28

  3. Incidence of dose-limiting toxicities (DLTs)

    Number of incidences of dose-limiting toxicities (DLTs)

    Measured: up to 28 weeks

  4. Change from Baseline in Systolic Blood Pressure

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

    Measured: Up to week 28

  5. Change from Baseline in Diastolic Blood Pressure

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

    Measured: up to 28 weeks

  6. Change from Baseline in Heart Rate

    Mean change from baseline in heart rate (bpm).

    Measured: up to 28 weeks

  7. Change from Baseline in Respiratory Rate

    Mean change from baseline in respiratory rate

    Measured: up to 28 weeks

  8. Change from Baseline in Body Temperature

    Mean change from baseline in body temperature (°C)

    Measured: up to 28 weeks

  9. Change from Baseline in PR Interval

    Mean change from baseline in PR interval (ms)

    Measured: up to 28 weeks

  10. Change from Baseline in QRS Duration

    Mean change from baseline in QRS duration (ms)

    Measured: up to 28 weeks

  11. Change from Baseline in QT Interval

    Mean change from baseline in QT interval (ms)

    Measured: up to 28 weeks

  12. Change from Baseline in QTc Interval

    Mean change from baseline in corrected QT interval (QTc)

    Measured: up to 28 weeks

Secondary outcomes (7)

  1. Area Under the Curve (AUC)

    Measurement of the area under the drug concentration-time curve

    Measured: Up to week 28

  2. Terminal Half-Life (T1/2)

    Measurement of the terminal half-life in days

    Measured: Up to week 28

  3. Incidence of Anti-Drug Antibodies (ADAs)

    Number of participants with detectable ADAs.

    Measured: Up to week 28

  4. ADA Titer Over Time

    Measurement of ADA titer over time

    Measured: Up to week 28

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

    Change in absolute peripheral B-cell count

    Measured: Up to week 28

  6. Change from Baseline in SLEDAI-2K Score

    Measurement of change in SLEDAI-2K score from baseline

    Measured: up to 28 weeks

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

    Measurement of change in UPCR from baseline

    Measured: up to 28 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 May 2026
  2. Study start30 Jun 2026
  3. Primary completionSep 2027 (estimated)
  4. Study completionSep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07564596
Sponsor's protocol ID
TNT119-SLE-102
Status last verified
Oct 2026
First submitted
27 Apr 2026
Last updated
20 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Budoprutug in people with Systemic Lupus Erthematosus, run by Climb Bio, Inc. at 10 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Climb Bio Study Director (+1 8668572596, clinicaltrials@climbbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Treatment-Emergent Adverse Events (TEAEs) (time frame: Up to week 28). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07564596.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.

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