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.
Trial summary
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… Read more about this study
- 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
- 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 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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- Qi deng
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Qi deng, Tianjin First Central Hospital
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
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Treatment of Refractory Immune-related Cytopenia With CD20 Monoclonal Antibody Combined With BTK Inhibitor (BTKi)
- ClinicalTrials.gov ID
- NCT07574073
- Acronym / sponsor ID
- 2026-50
- Conditions
- Anti-CD20 Monoclonal Antibody, BTK Inhibitors, Immune Thrombocytopenia (ITP), Autoimmune Hemolytic Anemia (AIHA)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Qi dengUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 31 May 2028 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 7 May 2026 (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.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Zuberitamab-Orelabrutinib combination therapy | Experimental | Drug: Anti-CD20 monoclonal antibody and the BTK inhibitorThis 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
- Peripheral superficial venous blood flow is unobstructed, capable of meeting the requirements for intravenous infusion;
Key exclusion criteria (15 listed)
- 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:
- 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;
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 |
|---|---|---|
| Anti-CD20 monoclonal antibody and the BTK inhibitorThis is a novel combination regimen of anti-CD20 monoclonal antibody plus BTKi, specifically designed for patients with refractory immune-related cytopenia. | Drug | Zuberitamab-Orelabrutinib combination therapy |
Primary outcome
Evaluate the Median overall response rate at 6 months of anti-CD20 monoclonal antibody and BTKi combination therapy in refractory immune-related cytopenia
Time frame: Six month after treatment initiation
Median overall response rate at 6 months after treatment initiation
3 secondary outcomes
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
Time frame: 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
Time frame: 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
Time frame: Up to three month after therapy
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 22 May 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
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.
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 10 inclusion and 15 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: opening soon, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the Median overall response rate at 6 months of anti-CD20 monoclonal antibody and BTKi combination therapy in refractory immune-related cytopenia (time frame: Six month after treatment initiation). 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 22 May 2026.