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New drug combo aims to tame stubborn blood disorders

NCT ID NCT07574073

Disease control Sponsor: Qi deng Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This early-phase study tests whether combining two drugs (Zuberitamab and Orelabrutinib) can help people with immune thrombocytopenia (ITP) or autoimmune hemolytic anemia (AIHA) that hasn't responded to other treatments. The drugs work together to calm the immune system and stop it from attacking the body's own blood cells. The study will enroll 30 adults and focus on safety and how well the combination works.

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

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 30 people

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

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

May 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 to 80 years

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: * Diagnosed with refractory immune-related cytopenia, including immune thrombocytopenic purpura (ITP) and autoimmune hemolytic anemia (AIHA); * Age ranging from 18 to 80 years old (inclusive of 18 and 80); * Expected survival time \> 12 months; * Good function of major organs: 1. liver function: ALT/AST \< 3 times the upper limit of normal; 2. kidney function: creatinine \< 100 μmol/L; 3. lung function: indoor oxygen saturation ≥ 95%; 4. heart function: left ventricular ejection fraction (LVEF) ≥ 50%; * Peripheral superficial venous blood flow is unobstructed, capable of meeting the requirements for intravenous infusion; * Karnofsky score ≥ 60, ECOG ≤ 2 points. Exclusion Criteria: * Women who are pregnant (with positive urine/blood pregnancy test results) or breastfeeding; * Those who have severe underlying heart diseases when participating in this study, including: 1. clinically significant atrial fibrillation (AF), 2. cardiac conduction block, 3. myocardial infarction (within 1 year), 4. congestive heart failure (CHF); 5. cardiac echocardiography LVEF \< 50%; 6. New York Heart Association (NYHA) cardiac function classification of III-IV grade; * Those with active bleeding or bleeding tendencies, and those who need to take anticoagulant drugs; * Those with organ dysfunction or uncontrollable coexisting diseases; * History of malignant tumors; * Those with active chronic hepatitis B or active hepatitis C; * Known history of human immunodeficiency virus (HIV) infection and/or acquired immunodeficiency syndrome; * Those with uncontrollable infectious diseases; * As determined by the investigator, other unsuitable conditions exist.

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Conditions

The condition(s) this trial relates to.

autoimmune hemolytic anemia 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-CD20 monoclonal antibody Autoimmune hemolytic anemia (AIHA) BTK inhibitors Immune thrombocytopenia (ITP) Refractory immune-related cytopenia

How to take part

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

  1. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  2. 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.

More trials for these conditions

Other studies related to the condition(s) this trial covers.