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New antibody drug aims to boost platelets in Hard-to-Treat ITP

NCT ID NCT07043946

Disease control Sponsor: Climb Bio, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-phase trial is testing a new drug called budoprutug (TNT119) in 24 adults with immune thrombocytopenia (ITP), a condition where the immune system destroys platelets, raising bleeding risk. Participants receive two IV doses and are monitored for safety, how the drug moves through the body, and any signs it helps raise platelet counts. The goal is to see if this approach is safe and worth studying further.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
budoprutug (TNT119), a monoclonal antibody given by IV infusion
What this could lead to
If it works, this could point toward a new treatment option for people with immune thrombocytopenia (ITP) who haven't responded to other therapies.
What could go wrong
This is an early, small trial (24 people) focused mainly on safety. It may not show clear benefit, and side effects are possible. Even if promising, more studies are needed.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 24 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2025

Expected to finish

Aug 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Aged 18 years at the time of consent. 2. Platelet count \< 30,000/µL despite an adequate trial of at least one prior therapeutic attempt. Platelet counts of \< 30,000/µL must be confirmed on 2 occasions at least 5 days apart, but no more than 14 days apart. 3. Partial thromboplastin time \< 1.5 x upper limit of normal (ULN), prothrombin time \< 1.5 x ULN, total bilirubin \< 1.5 x ULN unless due to Gilbert's syndrome, or an international normalized ratio \< 1.5 at screening. Exclusion Criteria: 1. CD19+ B cell count \< 80 cells/µL at Screening, or \< 40 cells/µL if B-cell depleting therapy was received within 24 weeks to 2 years prior. 2. Diagnosis of paroxysmal nocturnal hemoglobinuria, Evan's Syndrome, or other bleeding disorders affecting safety or data integrity. 3. Prior B-cell depleting therapy (e.g., rituximab) within 24 weeks before first dose or planned during the study. 4. Chronic use of anticoagulants or antiplatelet agents (e.g., aspirin, NSAIDs, thienopyridines) within 14 days before dosing through follow-up. Intermittent NSAID use is allowed. 5. Immunosuppressants (excluding corticosteroids) within 30 days or 5× half-life before Screening; alkylating agents within 180 days. 6. IVIg treatment within 90 days prior to Screening. 7. Active ITP treatment (other than steroids or TPO agonists) within 30 days or 5× half-life before first dose, unless approved by Medical Monitor. 8. Active, chronic, or latent infections including hepatitis B/C or HIV. 9. Active TB or high TB risk.

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Conditions

The condition(s) this trial relates to.

autoimmune thrombocytopenic purpura monoclonal gammopathy Purpura, Thrombocytopenic, Idiopathic thrombocytopenia due to immune destruction

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Anti-CD19 Biologics Immune thrombocytopenia (ITP) ITP Monoclonal

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    20 sites in 5 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Climb Bio Investigative Site #300201

    RECRUITING

    Thessaloniki, 57010, Greece

  • Climb Bio Investigative Site #300202

    RECRUITING

    Ioannina, 45500, Greece

  • Climb Bio Investigative Site #300203

    RECRUITING

    Chaïdári, Attica, 12462, Greece

  • Climb Bio Investigative Site #300204

    RECRUITING

    Athens, Attica, 11527, Greece

  • Climb Bio Investigative Site #340202

    RECRUITING

    San Pedro, Spain

  • Climb Bio Investigative Site #340203

    RECRUITING

    Valencia, 46010, Spain

  • Climb Bio Investigative Site #340204

    RECRUITING

    Madrid, 28041, Spain

  • Climb Bio Investigative Site #340206

    NOT_YET_RECRUITING

    Burgos, 9006, Spain

  • Climb Bio Investigative Site #359201

    RECRUITING

    Sofia, 1797, Bulgaria

  • Climb Bio Investigative Site #359202

    RECRUITING

    Plovdiv, 4002, Bulgaria

  • Climb Bio Investigative Site #359203

    RECRUITING

    Plovdiv, 4003, Bulgaria

  • Climb Bio Investigative Site #380208

    NOT_YET_RECRUITING

    Cherkasy, Ukraine

  • Climb Bio Investigative Site #381201

    RECRUITING

    Belgrade, Serbia

  • Climb Bio Investigative Site #381202

    RECRUITING

    Belgrade, Serbia

  • Climb Bio Investigative Site #381203

    RECRUITING

    Novi Sad, Serbia

  • Climb Investigative Site #2380203

    RECRUITING

    Kyiv, Ukraine

  • Climb Investigative Site #380201

    RECRUITING

    Lviv, Ukraine

  • Climb Investigative Site #380202

    RECRUITING

    Kyiv, Ukraine

  • Climb Investigative Site #380204

    RECRUITING

    Ivano-Frankivsk, Ukraine

  • Climb Investigative Site #380206

    RECRUITING

    Kyiv, Ukraine

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