Acute Graft-versus-Host DiseasePhase 2NCT06880419
Anti-CD25 rhMAb for aGVHD Prevention in High-Risk Adults Using the daGOAT Model
A Phase 2 study testing Recombinant Humanized Anti-CD25 Monoclonal Antibody Injection in people with Acute Graft-versus-Host Disease, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
Trial summary
To assess the efficacy and safety of using recombinant humanized anti-CD25 monoclonal antibody injection as a prophylactic strategy for reducing the incidence of severe acute graft-versus-host disease (aGVHD) in adult patients at intermediate to high risk, as predicted by the dynamic aGVHD Onset Anticipation Tianjin… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Acute Graft-versus-Host Disease
- What is being tested?
- Recombinant Humanized Anti-CD25 Monoclonal Antibody Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 1 siteChina
- Study dates
- 3 Mar 2025to 31 Dec 2026
- Phase
- Phase 2
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age ≥ 16 years, regardless of gender.
- Patients with hematologic disorders who are scheduled to receive allo-HSCT.
- Voluntarily join this study, sign the informed consent form, have good compliance, and be willing to cooperate with follow-up.
Who cannot join
- Patients who have received a second or multiple transplants.
- Patients who are allergic to, or intolerant of, a recombinant humanized anti-CD25 monoclonal antibody injection.
- Pregnant or lactating female patients or female patients who are unable to take effective contraceptive measures during the entire trial period.
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
Institute of Hematology & Blood Diseases Hospital
Tianjin, Tianjin Municipality, 300020
erlie jiang, +86-15122538106, zihua.zhang@zenithcro.com
About this study
Official title: A Prospective, Single-arm, Historically Controlled, Single-center Study for Preventing aGVHD, Post-allogeneic HSCT, in Adults at Moderate-to-high Risk Using Recombinant Humanized Anti-CD25 Monoclonal Antibody Based on the daGOAT Model
To assess the efficacy and safety of using recombinant humanized anti-CD25 monoclonal antibody injection as a prophylactic strategy for reducing the incidence of severe acute graft-versus-host disease (aGVHD) in adult patients at intermediate to high risk, as predicted by the dynamic aGVHD Onset Anticipation Tianjin (daGOAT) model, following allogeneic hematopoietic stem cell transplantation (allo-HSCT).
- Conditions
- Acute Graft-versus-Host Disease
- Being tested
- Recombinant Humanized Anti-CD25 Monoclonal Antibody Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant Humanized Anti-CD25 Monoclonal Antibody InjectionDrug
Model-predicted patients at high risk (HR): Recombinant humanized anti-CD25 monoclonal antibody: 50 mg/day when the post-transplant model predicts high risk in the second week post-prediction and 25 mg/day in the fourth and sixth weeks post-prediction. Administered in combination with conventional aGVHD prevention regimen.
Model-predicted patients at moderate risk (MR): Recombinant anti-CD25 humanized monoclonal antibody: 25 mg/day when the model predicts intermediate risk post-transplantation and at the 2nd, 4th, and 6th weeks post-prediction. Administered in combination with conventional aGVHD prevention regimen.
Model-predicted patients at low-risk (LR): A conventional aGVHD prevention regimen only was used.
| Study group | Role | What they receive |
|---|---|---|
| The group of daGOAT model prevention | Experimental | Model-predicted patients at high risk (HR): Recombinant humanized anti-CD25 monoclonal antibody: 50 mg/day when the post-transplant model predicts high risk in the second week post-prediction and 25 mg/day in the fourth and sixth weeks post-prediction. Administered in combination with conventional aGVHD prevention regimen.
Model-predicted patients at moderate risk (MR): Recombinant anti-CD25 humanized monoclonal antibody: 25 mg/day when the model predicts intermediate risk post-transplantation and at the 2nd, 4th, and 6th weeks post-prediction. Administered in combination with conventional aGVHD prevention regimen.
Model-predicted patients at low-risk (LR): A conventional aGVHD prevention regimen only was used. Receives: Drug: Recombinant Humanized Anti-CD25 Monoclonal Antibody Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of severe aGVHD (Grade III-IV) within 100 days post-transplantation
Measured: 100 days after transplantation
Secondary outcomes (11)
Incidence of aGVHD and aGVHD (any grade) in each target organ within 100 days post-transplantation
Measured: 100 days after transplantation
Engraftment rate
Measured: 180 days after transplantation
Disease relapse rate
Measured: 180 days after transplantation
Infection rate
Measured: 180 days after transplantation
Overall survival
Measured: 180 days after transplantation
Non-relapse mortality
Measured: 180 days after transplantation
GVHD-free relapse-free survival
Measured: 180 days after transplantation
Overall Response Rate of severe aGVHD treatment
Measured: 100 days after transplantation
Incidence of chronic GVHD
Measured: 180 days after transplantation
Adverse events
Measured: 180 days after transplantation
Total cost of treatment
Measured: 180 days after transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2025
- Study start3 Mar 2025
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Graft-versus-Host DiseaseStudies of the same condition, open and under way.
- More trials run by Institute of Hematology & Blood Diseases Hospital, ChinaThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 174 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06880419
- Sponsor's protocol ID
- IIT2024115
- Status last verified
- Feb 2025
- First submitted
- 11 Mar 2025
- Last updated
- 8 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-arm, Historically Controlled, Single-center Study for Preventing aGVHD, Post-allogeneic HSCT, in Adults at Moderate-to-high Risk Using Recombinant Humanized Anti-CD25 Monoclonal Antibody Based on the daGOAT Model
- ClinicalTrials.gov ID
- NCT06880419
- Acronym / sponsor ID
- IIT2024115
- Conditions
- Acute Graft-versus-Host Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 174 participants (estimated)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Study start
- 3 Mar 2025 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 17 Mar 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 assess the efficacy and safety of using recombinant humanized anti-CD25 monoclonal antibody injection as a prophylactic strategy for reducing the incidence of severe acute graft-versus-host disease (aGVHD) in adult patients at intermediate to high risk, as predicted by the dynamic aGVHD Onset Anticipation Tianjin (daGOAT) model, following allogeneic hematopoietic stem cell transplantation (allo-HSCT).
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The group of daGOAT model prevention | Experimental | Drug: Recombinant Humanized Anti-CD25 Monoclonal Antibody InjectionModel-predicted patients at high risk (HR): Recombinant humanized anti-CD25 monoclonal antibody: 50 mg/day when the post-transplant model predicts high risk in the second week post-prediction and 25 mg/day in the fourth and sixth weeks post-prediction. Administered in combination with conventional aGVHD prevention regimen. Model-predicted patients at moderate risk (MR): Recombinant anti-CD25 humanized monoclonal antibody: 25 mg/day when the model predicts intermediate risk post-transplantation and at the 2nd, 4th, and 6th weeks post-prediction. Administered in combination with conventional aGVHD prevention regimen. Model-predicted patients at low-risk (LR): A conventional aGVHD prevention regimen only was used. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 16 years, regardless of gender.
- Patients with hematologic disorders who are scheduled to receive allo-HSCT.
- Voluntarily join this study, sign the informed consent form, have good compliance, and be willing to cooperate with follow-up.
Key exclusion criteria (3 listed)
- Patients who have received a second or multiple transplants.
- Patients who are allergic to, or intolerant of, a recombinant humanized anti-CD25 monoclonal antibody injection.
- Pregnant or lactating female patients or female patients who are unable to take effective contraceptive measures during the entire trial period.
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 Antibody InjectionModel-predicted patients at high risk (HR): Recombinant humanized anti-CD25 monoclonal antibody: 50 mg/day when the post-transplant model predicts high risk in the second week post-prediction and 25 mg/day in the fourth and sixth weeks post-prediction. Administered in combination with conventional aGVHD prevention regimen. Model-predicted patients at moderate risk (MR): Recombinant anti-CD25 humanized monoclonal antibody: 25 mg/day when the model predicts intermediate risk post-transplantation and at the 2nd, 4th, and 6th weeks post-prediction. Administered in combination with conventional aGVHD prevention regimen. Model-predicted patients at low-risk (LR): A conventional aGVHD prevention regimen only was used. | Drug | The group of daGOAT model prevention |
Primary outcome
Incidence of severe aGVHD (Grade III-IV) within 100 days post-transplantation
Time frame: 100 days after transplantation
11 secondary outcomes
Incidence of aGVHD and aGVHD (any grade) in each target organ within 100 days post-transplantation
Time frame: 100 days after transplantation
Engraftment rate
Time frame: 180 days after transplantation
Disease relapse rate
Time frame: 180 days after transplantation
Infection rate
Time frame: 180 days after transplantation
Overall survival
Time frame: 180 days after transplantation
Non-relapse mortality
Time frame: 180 days after transplantation
GVHD-free relapse-free survival
Time frame: 180 days after transplantation
Overall Response Rate of severe aGVHD treatment
Time frame: 100 days after transplantation
Incidence of chronic GVHD
Time frame: 180 days after transplantation
Adverse events
Time frame: 180 days after transplantation
Total cost of treatment
Time frame: 180 days after transplantation
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 8 Aug 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Recombinant Humanized Anti-CD25 Monoclonal Antibody Injection in people with Acute Graft-versus-Host Disease, run by Institute of Hematology & Blood Diseases Hospital, China 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 3 inclusion and 3 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 8 Aug 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 erlie jiang (+86-15122538106, jiangerlie@ihcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of severe aGVHD (Grade III-IV) within 100 days post-transplantation (time frame: 100 days after transplantation). 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 8 Aug 2025.