EBV-T/NK LPDPhase 4NCT07029958
Improved Myeloablative Allogeneic Hematopoietic Stem Cell Transplantation Protocol for the Treatment of Epstein Barr Virus T/NK Lymphoproliferative Disease (EBV-T/NK LPD) and Prevention of Post Transplant Graft-versus-host Disease
A Phase 4 study testing recombinant humanized anti-CD25 monoclonal antibody in people with EBV-T/NK LPD, run by Beijing Children's Hospital at 1 site in China.
Trial summary
To investigate whether the addition of recombinant humanized anti-CD25 monoclonal antibody to the conventional EBV-T/NK LPD conditioning regimen can prevent acute and chronic GVHD after transplantation, improve the severity of GVHD and have a corresponding impact on other related post-transplant complications such as… Read more about this study
- Who is it for?
- Ages 0 to 18 years
- Conditions the study is for
- EBV-T/NK LPD
- What is being tested?
- recombinant humanized anti-CD25 monoclonal antibody
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 12 Nov 2024to 30 Oct 2029
- Phase
- Phase 4
- 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 0 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Meet the diagnosis of EBV-T/NK lymphoproliferative disease (EBV-T/NK LPD) according to the ICC2022 diagnostic criteria
- Plan to undergo allogeneic hematopoietic stem cell transplantation (allo HSCT) in our hospital
- Age ≤ 18 years old
- Sign informed consent form
- Meet one of the following conditions (haploid donors must meet one of the above conditions, unrelated donors must meet two of the above conditions): ① donor age≥40 years old; ② The donor source is unrelated donor or haplotype related female or collateral donor (brother sisters, etc.) with ≥ 1 point mismatch; ③ CD3≥4 x 10 ^ 8/kg before transplantation; ④ The primary disease is in an HLH (hemophagocytic lymphohistiocytosis) flare or active disease phase; ⑤ ATG (or ATLG (1:2)/ALG (1:20) equivalent dose)<10mg/kg
Who cannot join
- The expected survival period for multiple organ failure is no more than 3 months
- Not signing the informed consent form
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Children's Hospital Capital Medical University
Beijing, 100045
Jun Yang, +8601059612403, yangjundabby@outlook.com
About this study
To investigate whether the addition of recombinant humanized anti-CD25 monoclonal antibody to the conventional EBV-T/NK LPD conditioning regimen can prevent acute and chronic GVHD after transplantation, improve the severity of GVHD and have a corresponding impact on other related post-transplant complications such as poor engraftment, thrombotic microvascular disease, early EBV reactivation and relapse.
- Conditions
- EBV-T/NK LPD
- Being tested
- recombinant humanized anti-CD25 monoclonal antibody
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
recombinant humanized anti-CD25 monoclonal antibodyDrug
For children at high risk of GVHD, one of the following conditions must be met (haploidentical donors must meet one condition, while unrelated donors must meet two conditions):
- The donor is ≥40 years old;
- The donor is an unrelated donor with ≥1 locus mismatch, a haploidentical female donor, or collateral consanguinity (e.g., cousin, uncle/aunt);
- Pre-transplant CD3 count ≥4 x 10^8/kg;
- The primary disease is in an HLH (hemophagocytic lymphohistiocytosis) flare or active disease phase;
- ATG (or biologically equivalent doses of ATLG [1:2] or ALG [1:20]) <10mg/kg. Combining recombinant anti-CD25 humanized monoclonal antibody with conventional pretreatment regimen, before peripheral blood stem cell transfusion (i.e. 0d) and+3d, 1mg/kg，<40kg the maximum dose should not exceed25mg/dose, ≥40kg 1mg/kg, and the maximum dose should not exceed 50mg/dose.
| Study group | Role | What they receive |
|---|---|---|
| treatment group | Experimental | Not described Receives: Drug: recombinant humanized anti-CD25 monoclonal antibody |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of aGVHD
Measured: post-HSCT 100days
Secondary outcomes (4)
Incidence of TMA
Measured: post-HSCT 1year
Incidence of VOD
Measured: post-HSCT 1year
Overall survival
Measured: post-HSCT 1year
Incidence of adverse events
Measured: 30 days after discontinuation of medication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2025
- Study start12 Nov 2024
- Primary completion30 Oct 2029 (estimated)
- Study completion30 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EBV-T/NK LPDStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jun Yang, Beijing Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07029958
- Sponsor's protocol ID
- [2024]-Y-254-D
- Status last verified
- Jun 2025
- First submitted
- 12 Jun 2025
- Last updated
- 19 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The research results will be published in the form of an article in the future. Depending on the circumstances of the study, it may be possible to provide the relevant data upon request via email or other means.
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improved Myeloablative Allogeneic Hematopoietic Stem Cell Transplantation Protocol for the Treatment of Epstein Barr Virus T/NK Lymphoproliferative Disease (EBV-T/NK LPD) and Prevention of Post Transplant Graft-versus-host Disease
- ClinicalTrials.gov ID
- NCT07029958
- Acronym / sponsor ID
- [2024]-Y-254-D
- Conditions
- EBV-T/NK LPD
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Beijing Children's HospitalUniversity, hospital or other
- Study start
- 12 Nov 2024 (actual)
- Primary completion
- 30 Oct 2029 (estimated)
- Study completion
- 30 Oct 2029 (estimated)
- First posted
- 19 Jun 2025 (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.
To investigate whether the addition of recombinant humanized anti-CD25 monoclonal antibody to the conventional EBV-T/NK LPD conditioning regimen can prevent acute and chronic GVHD after transplantation, improve the severity of GVHD and have a corresponding impact on other related post-transplant complications such as poor engraftment, thrombotic microvascular disease, early EBV reactivation and relapse.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment group | Experimental | Drug: recombinant humanized anti-CD25 monoclonal antibody |
Who may qualify
- Ages
- 0 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Meet the diagnosis of EBV-T/NK lymphoproliferative disease (EBV-T/NK LPD) according to the ICC2022 diagnostic criteria
- Plan to undergo allogeneic hematopoietic stem cell transplantation (allo HSCT) in our hospital
- Age ≤ 18 years old
- Sign informed consent form
- Meet one of the following conditions (haploid donors must meet one of the above conditions, unrelated donors must meet two of the above conditions): ① donor age≥40 years old; ② The donor source is unrelated donor or haplotype related female or collateral donor (brother sisters, etc.) with ≥ 1 point mismatch; ③ CD3≥4 x 10 ^ 8/kg before transplantation; ④ The primary disease is in an HLH (hemophagocytic lymphohistiocytosis) flare or active disease phase; ⑤ ATG (or ATLG (1:2)/ALG (1:20) equivalent dose)<10mg/kg
Key exclusion criteria (2 listed)
- The expected survival period for multiple organ failure is no more than 3 months
- Not signing the informed consent form
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 |
|---|---|---|
| recombinant humanized anti-CD25 monoclonal antibodyFor children at high risk of GVHD, one of the following conditions must be met (haploidentical donors must meet one condition, while unrelated donors must meet two conditions): 1. The donor is ≥40 years old; 2. The donor is an unrelated donor with ≥1 locus mismatch, a haploidentical female donor, or collateral consanguinity (e.g., cousin, uncle/aunt); 3. Pre-transplant CD3 count ≥4 x 10^8/kg; 4. The primary disease is in an HLH (hemophagocytic lymphohistiocytosis) flare or active disease phase; 5. ATG (or biologically equivalent doses of ATLG [1:2] or ALG [1:20]) <10mg/kg. Combining recombinant anti-CD25 humanized monoclonal antibody with conventional pretreatment regimen, before peripheral blood stem cell transfusion (i.e. 0d) and+3d, 1mg/kg，<40kg the maximum dose should not exceed25mg/dose, ≥40kg 1mg/kg, and the maximum dose should not exceed 50mg/dose. | Drug | treatment group |
Primary outcome
Incidence of aGVHD
Time frame: post-HSCT 100days
4 secondary outcomes
Incidence of TMA
Time frame: post-HSCT 1year
Incidence of VOD
Time frame: post-HSCT 1year
Overall survival
Time frame: post-HSCT 1year
Incidence of adverse events
Time frame: 30 days after discontinuation of medication
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 19 Jun 2025.
- Individual participant dataSharing planned: Undecided. The research results will be published in the form of an article in the future. Depending on the circumstances of the study, it may be possible to provide the relevant data upon request via email or other means.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing recombinant humanized anti-CD25 monoclonal antibody in people with EBV-T/NK LPD, run by Beijing Children's Hospital at 1 site in China.
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 5 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 19 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Contact Jun Yang (+86 01059612403, yangjundabby@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of aGVHD (time frame: post-HSCT 100days). 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 19 Jun 2025.