Systemic Lupus ErythematosusPhase 1NCT07011043
A Phase 1b Study of Budoprutug in Systemic Lupus Erythematosus (SLE)
A Phase 1 study testing Budoprutug in people with Systemic Lupus Erythematosus, run by Climb Bio, Inc. at 18 sites in 8 countries.
Trial summary
The main objective is to assess the safety and tolerability of budoprutug in adults with SLE. Pharmacokinetics, pharmacodynamics, and preliminary clinical efficacy will also be assessed. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Systemic Lupus Erythematosus
- 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
- 18 sitesin 8 countries
- Study dates
- 10 Jul 2025to Apr 2027
- Phase
- Phase 1
- 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 >=8.
- Inadequate response to at least 2 therapeutic interventions, including at least one oral immunosuppressive or biologic standard-of care therapy.
Who cannot join
- Active neuropsychiatric SLE.
- 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.
- Active systemic infection or history of chronic, recurrent, latent, or recent serious infections.
Trial locations and contacts
18 sites in 8 countries. Contact the study team or a site near you to ask about taking part.
18 sites in 8 countries
Ukraine6 sites, 6 recruiting
- Recruiting
Climb Bio Investigative Site #380102
Ivano-Frankivsk
- Recruiting
Climb Bio Investigative Site #380103
Kyiv
- Recruiting
Climb Bio Investigative Site #380106
Kyiv
- Recruiting
Climb Bio Investigative Site #380101
Ternopil
- Recruiting
Climb Bio Investigative Site #380104
Vinnytsia
- Recruiting
Climb Bio Investigative Site #380105
Vinnytsia
United States2 sites, 2 recruiting
- Recruiting
Climb Bio Investigative Site #100104
Allen, Texas, 75013
- Recruiting
Climb Bio Investigative Site #100101
San Antonio, Texas, 78215
Bulgaria2 sites, 2 recruiting
- Recruiting
Climb Bio Investigative Site# 359101
Plovdiv, 4002
- Recruiting
Climb Bio Investigative Site# 359102
Sofia, 1618
Georgia2 sites, 2 recruiting
- Recruiting
Climb Bio Investigative Site #995102
Tbilisi, 0112
- Recruiting
Climb Bio Investigative Site #995101
Tbilisi, 0141
Greece2 sites, 2 recruiting
- Recruiting
Climb Bio Investigative Site# 300102
Exochi, Thessaloniki, 57010
- Recruiting
Climb Bio Investigative Site# 300103
Thessaloniki, Thessaloniki, 54642
Spain2 sites, 2 recruiting
- Recruiting
Climb Bio Investigative Site# 340102
A Coruña, 15006
- Recruiting
Climb Bio Investigative Site# 340101
Sabadell, Barcelona, 08208
Puerto Rico1 site, 1 recruiting
- Recruiting
Climb Bio Investigative Site #100103
Caguas
Romania1 site, 1 recruiting
- Recruiting
Climb Bio Investigative Site# 400101
Cluj-Napoca, 400006
About this study
Official title: 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)
The main objective is to assess the safety and tolerability of budoprutug in adults with SLE. Pharmacokinetics, pharmacodynamics, and preliminary clinical efficacy will also be assessed.
Read the detailed description
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, open-label study will evaluate budoprutug administered as a single intravenous infusion 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 following a single infusion.
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- Budoprutug
- Keywords
- Lupus, SLE, Biologics, Open-label, Monoclonal, Anti-CD19
- Medical subject headings
- Lupus Erythematosus, Systemic
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 of study
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Dose Level A | Experimental | Not described Receives: Drug: Budoprutug |
| Cohort 2: Dose Level B | Experimental | Not described Receives: Drug: Budoprutug |
| Cohort 3: Dose Level C | Experimental | Not described Receives: Drug: Budoprutug |
| Cohort 4: Dose Level D | Experimental | Not described Receives: Drug: Budoprutug |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Number of participants experiencing TEAEs, graded per NCI CTCAE v5.0.
Measured: Up to Week 24
Incidence of Clinical Laboratory Abnormalities
Number of participants with clinically significant laboratory abnormalities.
Measured: Up to Week 24
Change from Baseline in Systolic Blood Pressure
Mean change from baseline in systolic blood pressure (mmHg).
Measured: Up to Week 24
Change from Baseline in Diastolic Blood Pressure
Mean change from baseline in diastolic blood pressure (mmHg).
Measured: Up to Week 24
Change from Baseline in Heart Rate
Mean change from baseline in heart rate (bpm).
Measured: Up to Week 24
Change from Baseline in Respiratory Rate
Mean change from baseline in respiratory rate.
Measured: Up to Week 24
Change from Baseline in Body Temperature
Mean change from baseline in body temperature (°C).
Measured: Up to Week 24
Change from Baseline in PR Interval
Mean change from baseline in PR interval (ms).
Measured: Up to Week 24
Change from Baseline in QRS Duration
Mean change from baseline in QRS duration (ms).
Measured: Up to Week 24
Change from Baseline in QT Interval
Mean change from baseline in QT interval (ms).
Measured: Up to Week 24
Change from Baseline in QTc Interval
Mean change from baseline in corrected QT interval (QTc).
Measured: Up to Week 24
Secondary outcomes (9)
Area Under the Curve (AUC) of Budoprutug
Measurement of the area under the drug concentration-time curve.
Measured: Up to Week 24
Maximum Observed Plasma Concentration (Cmax)
Measurement of the maximum observed plasma concentration.
Measured: Up to Week 24
Time to Maximum Observed Concentration (Tmax)
Measurement of the time to maximum observed concentration.
Measured: Up to Week 24
Terminal Half-Life (T1/2)
Measurement of the terminal half-life in days.
Measured: Up to Week 24
Apparent Clearance (CL/F) of budoprutug
Measurement of the apparent clearance in L/hour.
Measured: Up to Week 24
Volume of Distribution (Vd)
Measurement of the volume of distribution in liters.
Measured: Up to Week 24
Change from Baseline in Circulating B Cell Count
Change in absolute number of CD19+ B cells in peripheral blood.
Measured: Up to Week 24
Incidence of Anti-Drug Antibodies (ADAs)
Number of participants with detectable ADAs.
Measured: Up to Week 24
ADA Titer Over Time
Measurement of ADA titer over time.
Measured: Up to Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2025
- Study start10 Jul 2025
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- This is an open-label study in which subjects will be enrolled into four single-dose ascending cohorts. Each subject's participation will last approximately 198 days, including a 30-day screening period, a 1-day treatment period, and follow-up through Week 24.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Climb Bio, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Climb Bio, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07011043
- Sponsor's protocol ID
- TNT119-SLE-101
- Status last verified
- Mar 2026
- First submitted
- 6 May 2025
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07011043
- Acronym / sponsor ID
- TNT119-SLE-101
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- Lupus, SLE, Biologics, Open-label, Monoclonal, Anti-CD19
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Climb Bio, Inc.Industry (pharma, biotech, devices)
- Study start
- 10 Jul 2025 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 8 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objective is to assess the safety and tolerability of budoprutug in adults with SLE. Pharmacokinetics, pharmacodynamics, and preliminary clinical efficacy will also be assessed.
Detailed description
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, open-label study will evaluate budoprutug administered as a single intravenous infusion 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 following a single infusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- This is an open-label study in which subjects will be enrolled into four single-dose ascending cohorts. Each subject's participation will last approximately 198 days, including a 30-day screening period, a 1-day treatment period, and follow-up through Week 24.
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Dose Level A | Experimental | Drug: Budoprutug |
| Cohort 2: Dose Level B | Experimental | Drug: Budoprutug |
| Cohort 3: Dose Level C | Experimental | Drug: Budoprutug |
| Cohort 4: Dose Level D | Experimental | Drug: Budoprutug |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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 >=8.
- Inadequate response to at least 2 therapeutic interventions, including at least one oral immunosuppressive or biologic standard-of care therapy.
Key exclusion criteria (3 listed)
- Active neuropsychiatric SLE.
- 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.
- Active systemic infection or history of chronic, recurrent, latent, or recent serious infections.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BudoprutugAlso: TNT119Single IV dose of study product on Day 1 of study | Drug | Cohort 1: Dose Level A, Cohort 2: Dose Level B, Cohort 3: Dose Level C, Cohort 4: Dose Level D |
Primary outcome
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Time frame: Up to Week 24
Number of participants experiencing TEAEs, graded per NCI CTCAE v5.0.
Incidence of Clinical Laboratory Abnormalities
Time frame: Up to Week 24
Number of participants with clinically significant laboratory abnormalities.
Change from Baseline in Systolic Blood Pressure
Time frame: Up to Week 24
Mean change from baseline in systolic blood pressure (mmHg).
Change from Baseline in Diastolic Blood Pressure
Time frame: Up to Week 24
Mean change from baseline in diastolic blood pressure (mmHg).
Change from Baseline in Heart Rate
Time frame: Up to Week 24
Mean change from baseline in heart rate (bpm).
Change from Baseline in Respiratory Rate
Time frame: Up to Week 24
Mean change from baseline in respiratory rate.
Change from Baseline in Body Temperature
Time frame: Up to Week 24
Mean change from baseline in body temperature (°C).
Change from Baseline in PR Interval
Time frame: Up to Week 24
Mean change from baseline in PR interval (ms).
Change from Baseline in QRS Duration
Time frame: Up to Week 24
Mean change from baseline in QRS duration (ms).
Change from Baseline in QT Interval
Time frame: Up to Week 24
Mean change from baseline in QT interval (ms).
Change from Baseline in QTc Interval
Time frame: Up to Week 24
Mean change from baseline in corrected QT interval (QTc).
9 secondary outcomes
Area Under the Curve (AUC) of Budoprutug
Time frame: Up to Week 24
Maximum Observed Plasma Concentration (Cmax)
Time frame: Up to Week 24
Time to Maximum Observed Concentration (Tmax)
Time frame: Up to Week 24
Terminal Half-Life (T1/2)
Time frame: Up to Week 24
Apparent Clearance (CL/F) of budoprutug
Time frame: Up to Week 24
Volume of Distribution (Vd)
Time frame: Up to Week 24
Change from Baseline in Circulating B Cell Count
Time frame: Up to Week 24
Incidence of Anti-Drug Antibodies (ADAs)
Time frame: Up to Week 24
ADA Titer Over Time
Time frame: Up to Week 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Study Director study director
Climb Bio, Inc.
18 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Budoprutug in people with Systemic Lupus Erythematosus, run by Climb Bio, Inc. at 18 sites in 8 countries.
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 3 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 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Ukraine, United States, Bulgaria, Georgia, Greece and 3 more countries. 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 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.
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 (+1 866 857 2596, 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 24). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Mar 2026; AzTrials last refreshed its copy on 7 Nov 2026.