Anti-CD20 Monoclonal AntibodyPhase 1NCT07574073

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

A Phase 1 study testing Anti-CD20 monoclonal antibody and the BTK inhibitor in people with Anti-CD20 Monoclonal Antibody and BTK Inhibitors, run by Qi deng.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record

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Trial summary

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Anti-CD20 Monoclonal Antibody, BTK Inhibitors, Immune Thrombocytopenia (ITP)
What is being tested?: Anti-CD20 monoclonal antibody and the BTK inhibitor
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: No sites listed yet
Study dates: 1 Jun 2026to 31 May 2028
Phase: Phase 1

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 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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;

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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.

Who cannot join

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);

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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.

About this study

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

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).

Conditions: Anti-CD20 Monoclonal Antibody, BTK Inhibitors, Immune Thrombocytopenia (ITP), Autoimmune Hemolytic Anemia (AIHA)
Being tested: Anti-CD20 monoclonal antibody and the BTK inhibitor
Medical subject headings: Purpura, Thrombocytopenic, Idiopathic, Anemia, Hemolytic, Autoimmune

What participants receive

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

Anti-CD20 monoclonal antibody and the BTK inhibitorDrug
This is a novel combination regimen of anti-CD20 monoclonal antibody plus BTKi, specifically designed for patients with refractory immune-related cytopenia.

Study groups in NCT07574073
Study group	Role	What they receive
Zuberitamab-Orelabrutinib combination therapy	Experimental	This study is designed as a non-randomized, single-arm, open-label clinical trial. Patients with refractory immune-related cytopenia, including immune thrombocytopenia (ITP) and autoimmune hemolytic anemia (AIHA), are intended for enrollment. The treatment regimen and schedule are as follows: anti-CD20 monoclonal antibody (Zuberitamab): 100 mg per dose on Days 1, 8, 15, and 22; BTK inhibitor (Orelabrutinib): 50 mg once daily (qd) from Day 1 to Day 90. Receives: Drug: Anti-CD20 monoclonal antibody and the BTK inhibitor

What is being measured

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

Evaluate the Median overall response rate at 6 months of anti-CD20 monoclonal antibody and BTKi combination therapy in refractory immune-related cytopenia
Median overall response rate at 6 months after treatment initiation
Measured: Six month after treatment initiation

Secondary outcomes (3)

Evaluate the early overall response rate 3 months after the start of anti-CD20 monoclonal antibody and BTKi combination therapy in refractory immune-related cytopenia
The early overall response rate 3 months after the start of treatment
Measured: Three month after therapy
Evaluate the sustained remission rate that lasts for 6 months after achieving remission following anti-CD20 monoclonal antibody and BTKi combination therapy in refractory immune-related cytopenia
The sustained remission rate that lasts for 6 months after achieving remission
Measured: Six month after achieving remission
Evaluate the Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) of anti-CD20 monoclonal antibody and BTKi combination therapy in refractory immune-related cytopenia
The incidence and severity of therapy related toxic reactions (including infections, bleeding, cardiac toxicity)
Measured: Up to three month after therapy

Timeline

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

1 Jun 202631 May 2028

First posted7 May 2026
Study start1 Jun 2026 (estimated)
Primary completion31 May 2028 (estimated)
Study completion31 May 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Anti-CD20 Monoclonal AntibodyStudies 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 30 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07574073
Sponsor's protocol ID: 2026-50
Status last verified: May 2026
First submitted: 1 May 2026
Last updated: 22 May 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No