ClinicalTrials.gov record NCT07574073

CD20 Monoclonal Antibody Combined With BTK Inhibitor for the Treatment of Refractory Immune-related Cytopenia

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Aug 22, 2026

Clinical Study on the Treatment of Refractory Immune-related Cytopenia With CD20 Monoclonal Antibody Combined With BTK Inhibitor (BTKi)

About this page. This page shows the study's official ClinicalTrials.gov record ↗, with added help to make it easier to understand. We explain medical terms, highlight key details in plain language, and suggest questions you may want to ask the study team.

The record is periodically copied from ClinicalTrials.gov and may lag behind changes. AI summaries are checked by software, not a clinician.Read moreShow less

The official record is written by the study sponsor and published on ClinicalTrials.gov. It may not always reflect the latest changes. Before making any decisions, please confirm important information with the study team and your own healthcare team.

Where you see "AI summary", AI was used to create a plain-language explanation and software checked it against the source. It has not been reviewed by a clinician, so it may contain mistakes or leave out important details.

StatusNot yet recruitingThe study has been registered but has not started enrolling. Sites and contacts may not be listed yet.

Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.

PhasePhase 1An early-stage study, usually small, mainly to check safety, side effects and how much of a treatment can be given. Whether it works is not the main question yet.

Age18 years old to 80 years old

SexAll

AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This Phase 1, single-arm, open-label study tests a combination of the anti-CD20 antibody Zuberitamab and the BTK inhibitor orelabrutinib in people with refractory immune thrombocytopenia (ITP) or autoimmune hemolytic anemia (AIHA). Participants receive Zuberitamab on Days 1, 8, 15, and 22 and orelabrutinib 50 mg daily for 90 days. The study will measure response rates at 3 and 6 months, duration of sustained remission, and safety including infections, bleeding, and cardiac toxicity.

What it is studying. The study evaluates the clinical activity (overall response at 3 and 6 months and duration of sustained remission) and the safety profile (treatment-emergent adverse events such as infections, bleeding, and cardiac toxicity) of the Zuberitamab–orelabrutinib combination in people with refractory ITP or AIHA.

What the researchers hope to learn. To measure overall and early response rates, the rate of sustained remission, and the incidence and severity of treatment-emergent adverse events for the Zuberitamab–orelabrutinib combination in refractory immune-related cytopenias, and to provide data to support or inform future combined use.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

This study aims to utilize anti-CD20 monoclonal antibodies to eliminate peripheral B cells and reduce the mechanism of autoantibody production, as well as combine the mechanism of BTK inhibitors (BTKi) blocking the B cell receptor signaling pathway and inhibiting B cell activation and proliferation, for the treatment of refractory immune-related cytopenia. In this study, it includes the salvage treatment of immune thrombocytopenia (ITP) and autoimmune hemolytic anemia (AIHA), expecting to achieve a synergistic and enhancing effect. This study aims to select Zuberitamab, a human-mouse chimeric anti-CD20 monoclonal antibody, and the BTKi Orelabrutinib as combination therapy options. The clinical efficacy of the Zuberitamab-Orelabrutinib combination therapy (overall response rate, duration of sustained remission) will be evaluated, along with its safety profile (including infections, bleeding, cardiac toxicity), to provide a theoretical basis for their combined use in treating refractory immune-related thrombocytopenia (ITP and AIHA).

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Drug: Anti-CD20 monoclonal antibody and the BTK inhibitor

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

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:
liver function: ALT/AST < 3 times the upper limit of normal;
kidney function: creatinine < 100 μmol/L;
lung function: indoor oxygen saturation ≥ 95%;
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:
clinically significant atrial fibrillation (AF),
cardiac conduction block,
myocardial infarction (within 1 year),
congestive heart failure (CHF);
cardiac echocardiography LVEF < 50%;
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.

Study description and what participation involves

The registry record has no detailed description beyond the summary above.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants will receive the study combination: the anti‑CD20 monoclonal antibody Zuberitamab given by intravenous infusion on Days 1, 8, 15 and 22, plus Orelabrutinib 50 mg once daily from Day 1 to Day 90. They will attend regular clinic visits for drug administration or safety checks, blood tests, and heart monitoring (including measures such as LVEF and oxygen saturation). Women will be screened for pregnancy; all participants will be monitored for infections, bleeding, and other adverse effects. Response assessments are planned at about 3 and 6 months after starting treatment, with safety monitoring up to three months after therapy.

How the study is structured. A non-randomized, single-arm, open-label Phase 1 treatment trial. All participants receive both study drugs: Zuberitamab 100 mg (given on Days 1, 8, 15, 22) and orelabrutinib 50 mg once daily from Day 1 through Day 90. The trial records clinical responses at specified time points and tracks adverse events during and after treatment.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

This is an early-phase study, mainly about safety and dose. What is already known about this treatment?
The registry says recruitment has not started. When is it expected to open, and can I register interest now?
No sites are listed on the registry yet. Where will the study take place?
Which of the eligibility criteria would need to be checked with tests before I could join?

More on autoimmune hemolytic anemia

Clinical trials49 trials listed for autoimmune hemolytic anemiaEvery trial the registry lists for autoimmune hemolytic anemia, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in autoimmune hemolytic anemia researchLatest monthly update: September 2026. Includes: Negative DAT cases. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start: Jun 1, 2026 (estimated)
Primary completion: May 31, 2028 (estimated)
Study completion: May 31, 2028 (estimated)
Target enrollment: 30 participants (estimated)
Last updated on registry: May 22, 2026
Data verified: Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor: Qi deng

Participating sites

Study locations have not been posted on ClinicalTrials.gov yet. This study is not yet recruiting, so sites may be added when recruitment begins.

Terms used on this page · explanations by MedicalUpdates.ai

refractory: A condition that has not responded to a treatment. 'Relapsed' means it responded and then came back; 'refractory' means it did not respond in the first place.
upper limit of normal: The highest value of a blood test that a laboratory considers normal. Criteria such as '≤ 3 × ULN' mean the result must be no more than three times that value.
Karnofsky: A scale from 100 (no complaints) down to 0 that describes how well a person can carry out daily activities. Studies often require a minimum score.
ECOG: A scale from 0 to 5 that describes how a person's condition affects daily activity. 0 means fully active; 1 means restricted in strenuous activity; 2 means able to self-care but unable to work; higher numbers mean more limitation.
echocardiography: An ultrasound scan of the heart. A transesophageal echocardiogram is done through a probe passed into the food pipe for a closer view.
Inclusion Criteria: The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria: The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

← Back to clinical trials