CClinicalTrials.gg
Not yet recruitingNCT07261215Updated Dec 3, 2025

Zuberitamab for EBV Infection Post-Allo-HSCT

A Phase 2 interventional study of Zuberitamab in HSCT and EBV Infection, sponsored by Institute of Hematology & Blood Diseases Hospital, China. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-03.

Sponsored by Institute of Hematology & Blood Diseases Hospital, China · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

EBV DNAemia is defined as the presence of EBV-DNA load in peripheral blood exceeding the normal threshold, serving as a key diagnostic indicator for EBV-associated post-transplant lymphoproliferative disorder (EBV-PTLD). According to the European Conference on Infections in Leukemia (ECIL-6) guidelines, regular monitoring of peripheral blood EBV-DNA levels via quantitative real-time PCR (qPCR) is recommended starting from the first month after allogeneic hematopoietic stem cell transplantation (allo-HSCT), with a weekly frequency sustained for at least 4 months post-transplant. For HSCT patients who develop EBV DNAemia, preemptive therapy should be initiated promptly. EBV-PTLD is a serious complication that may progress rapidly; if not diagnosed and treated in a timely manner, mortality rates can reach 60-80%. Current guidelines recommend CD20 monoclonal antibody (rituximab) as the first-line preemptive treatment. The response rate to rituximab is approximately 84%. The typical regimen consists of 375 mg/m² per dose, administered weekly, with 1-4 doses generally sufficient to achieve treatment goals. However, a subset of patients exhibits poor response to first-line therapy and requires second-line interventions, such as EBV-specific cytotoxic T lymphocytes (EBV-CTLs), donor lymphocyte infusion, or combination chemotherapy.

Zuberitamab is a novel anti-CD20 monoclonal antibody and the first Class 1 innovative biologics targeting CD20 developed in China. Preclinical studies have demonstrated that zuberitamab exhibits stronger antibody-dependent cellular cytotoxicity (ADCC) activity compared to rituximab. In a pivotal Phase III registrational clinical study, zuberitamab combined with CHOP (Hi-CHOP) was evaluated head-to-head against R-CHOP in patients with diffuse large B-cell lymphoma (DLBCL). The results showed an improvement in the complete response (CR) rate by more than 8% (85.7% vs. 77.3%, P = 0.038). These findings indicate that zuberitamab holds significant advantages over rituximab in terms of both biological activity and clinical efficacy. Based on this evidence, we have initiated a Phase II clinical trial to evaluate the efficacy and safety of zuberitamab as first-line preemptive therapy for EBV infection. This is a prospective Phase II clinical trial enrolling patients with EBV infection following transplantation. Zuberitamab will be administered as first-line preemptive therapy.

02

Conditions studied

  • HSCT
  • EBV Infection
03

In context

Epstein-Barr Virus Infections

159 studies on the registry are indexed under Epstein-Barr Virus Infections; 55 are open to participants now.

This study's planned enrollment of 20 is below the median of 28 across 105 interventional studies indexed under Epstein-Barr Virus Infections.

Browse Epstein-Barr Virus Infections studies →

Lead sponsor

Institute of Hematology & Blood Diseases Hospital, China is the lead sponsor of 398 studies on the registry; 293 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Underwent allogeneic hematopoietic stem cell transplantation (HSCT).
  2. Documented EBV infection, defined as either:

    EBV DNAemia (EBV-DNA ≥400 copies/mL in plasma), or Pathologically confirmed EBV-associated lymphoproliferative disease with positive EBER by in situ hybridization.

  3. Age ≥18 years, regardless of gender.
  4. Negative for HIV, HBV, and HCV.
  5. Eastern Cooperative Oncology Group Performance Status (ECOG-PS) score of 0-2.
  6. Provision of signed informed consent prior to any study-related procedures. For patients aged 18 or above, consent must be provided by the patient themselves or an immediate family member. If obtaining consent directly from the patient is deemed medically detrimental to their condition, consent may be provided by a legal guardian or an immediate family member.

Exclusion criteria

Exclusion Criteria:

  • 1. Presence of uncontrolled infection requiring mechanical ventilation or hemodynamic instability at the time of enrollment.

    2. Diagnosis of clinically significant severe hepatic insufficiency (defined as Child-Pugh Class C) within 5 days prior to enrollment.

    3. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels exceeding 5 times the upper limit of normal (ULN), or serum total bilirubin exceeding 2 times ULN, within 5 days prior to enrollment.

    4. Diagnosis of end-stage renal dysfunction with a creatinine clearance rate of \<10 mL/min within 5 days prior to enrollment.

    5. Concurrent diagnosis of moderate hepatic insufficiency (defined as Child-Pugh Class B) and moderate renal dysfunction (defined as creatinine clearance rate \<50 mL/min).

    6. Cardiac function or disease meeting any of the following criteria:

    1. Long QT syndrome or QTc interval >480 ms.
    2. Complete left bundle branch block, second-degree or third-degree atrioventricular block.
    3. Severe, uncontrolled arrhythmia requiring pharmacological intervention.
    4. New York Heart Association (NYHA) functional classification ≥ Class II.
    5. Left ventricular ejection fraction (LVEF) \<50%.
    6. History of myocardial infarction, unstable angina, severe unstable ventricular arrhythmia, or any other clinically significant arrhythmia requiring treatment within 6 months prior to enrollment; history of clinically significant pericardial disease; or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.

      7. Presence of uncontrolled severe acute graft-versus-host disease (aGVHD). 8. Evidence of active HIV replication prior to enrollment; detectable HCV antibody and HCV-RNA positivity within 90 days prior to enrollment; or HBsAg positivity. Known seropositivity for HIV or active hepatitis C virus.

      9. Presence of psychiatric disorders or other conditions that would compromise the patient's ability to comply with study treatment and monitoring requirements.

      10. Inability or unwillingness to provide written informed consent. 11. Patients deemed ineligible by the investigator due to other specific circumstances.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Zuberitamab treatment

    Drug: Zuberitamab

Interventions

  • DrugZuberitamab

    Zuberitamab will be administered as first-line preemptive therapy at a dose of 375 mg/m² on day 1 of each cycle (one cycle = 7 days).

06

What researchers measure

Primary outcomes

  1. EBV-DNA clearance rate

    Time frame: 28 days after treatment

Secondary outcomes

  1. overall survival (OS)

    Time frame: 180days

  2. relapse-free survival (RFS)

    Time frame: 180 days

  3. Treatment-related mortality

    Time frame: 180 days

  4. Incidence of post-transplant lymphoproliferative disease (PTLD)

    Time frame: 180 days

  5. Incidence of hemophagocytic syndrome

    Time frame: 180 days

  6. Infection rates

    Time frame: 180 days

  7. use of second-line therapy of anti-EBV

    Time frame: 180 days

  8. AE

    incidence of adverse events as assessed by the NCI CTCAE version 5.0 criteria

    Time frame: 180 days

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 3, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07261215
Lead sponsor
Institute of Hematology & Blood Diseases Hospital, China
Responsible party
Sponsor
First posted
Dec 3, 2025
Start date
Jan 14, 2026 (estimated)
Primary completion
Oct 31, 2026 (estimated)
Completion
Oct 31, 2026 (estimated)
Last update
Dec 3, 2025

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion