cGVHDPhase 4NCT06364319
Efficacy and Safety of Anti-CD25 rhMAb in the Treatment of Steroid-Refractory cGVHD
A Phase 4 study testing anti-CD25 rhMAb, Prednisone and Ruxolitinib in people with cGVHD, run by Peking University People's Hospital.
Trial summary
The study plan aims to include patients who have been diagnosed with steroid-refractory chronic GVHD in the liver following allogeneic hematopoietic stem cell transplantation. After obtaining informed consent, the patients will receive a treatment regimen consisting of the Anti-CD25 rhMAb in combination with… Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- cGVHD
- What is being tested?
- anti-CD25 rhMAb, Prednisone and Ruxolitinib
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 15 Jul 2026to 30 Jun 2028
- 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 16 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age 16 and 65 years
- Received allogeneic hematopoietic stem cell transplantation
- Developed chronic GVHD in the liver after transplantation
- Ineffective prednisone treatment prior to screening
- Received ≤4 lines of systemic therapy prior to screening
- After informed consent, the patient agreed to receive anti-CD25 rhMAb treatment
Who cannot join
- Elevation of bilirubin, ALT, or alkaline phosphatase due to reasons other than chronic GVHD
- No prior treatment with prednisone
- Overlap syndrome
- Uncontrolled active infection
- Organ failure
- Early progression or recurrence of hematologic diseases
Show all 9Show fewer
- Allergy to anti-CD25 rhMAb
- Received other interleukin-2 receptor monoclonal antibody treatment due to various reasons within one month after transplantation
- Participated in other clinical studies within one month
About this study
Official title: Study on the Efficacy and Safety of Anti-CD25 rhMAb in the Treatment of Steroid-Refractory Chronic Graft-Versus-Host Disease (cGVHD) of the Liver Following Allogeneic Hematopoietic Stem Cell Transplantation.
The study plan aims to include patients who have been diagnosed with steroid-refractory chronic GVHD in the liver following allogeneic hematopoietic stem cell transplantation. After obtaining informed consent, the patients will receive a treatment regimen consisting of the Anti-CD25 rhMAb in combination with prednisone, cyclosporine, and ruxolitinib.The objective is to assess the effectiveness and safety of Anti-CD25 rhMAb in the treatment of severe chronic GVHD affecting the liver.
- Conditions
- cGVHD
- Being tested
- anti-CD25 rhMAb, Prednisone, Ruxolitinib, Cyclosporine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anti-CD25 rhMAbDrug
1 mg/kg/day administered IV day 1, 4, and 8, then weekly for 6 doses. For patients achieving partial remission, an extra dose of Anti-CD25 rhMAb can be given on days 39 and 49.
PrednisoneDrug
Maintain pre-screening dose
RuxolitinibDrug
10mg, BID PO
CyclosporineDrug
1.25mg/kg, BID PO/IV, target:150-250ng/ml
| Study group | Role | What they receive |
|---|---|---|
| Anti-CD25 rhMAb + traditional therapy | Experimental | Not described Receives: Drug: anti-CD25 rhMAb; Drug: Prednisone; Drug: Ruxolitinib; Drug: Cyclosporine |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall response rate (ORR)
ORR is defined as the percentage of complete response (CR) and partial response (PR).
Measured: 56 days
Secondary outcomes (10)
duration of response（DOR）
DOR is defined as the duration calculated from the time of achieving PR or CR until the progression of GVHD, the addition of other systemic immunosuppressive therapy, or death.
Measured: 1 year
patient-reported outcomes (PRO)
the unabbreviated scale title is the Lee Chronic GVHD Symptom Scale.the minimum and maximum are 0 and 100, and higher scores mean a worse outcome.
Measured: 1 year
disease-free survival (DFS)
DFS is defined as the duration of survival after treatment in which the original hematologic disease is in a state of complete remission.
Measured: 1 year
failure-free survival (FFS)
Events that are considered as failures include the onset of new chronic GVHD, relapse, and death.
Measured: 1 year
non-relapse mortality (NRM)
NRM is defined as death due to reasons other than progression/relapse of hematologic disease.
Measured: 1 year
overall survival （OS）
OS is defined as the time from treatment until death from any cause or the last follow-up.
Measured: 1 year
adverse drug reactions (ADR)
The occurrence of various organ toxicities related to treatment that emerge following treatment.
Measured: 1 year
Best Overall Response Rate (ORR) of Overall cGVHD
CR + PR Rate of Overall cGVHD
Measured: 1 year
Immune Reconstitution
Humoral immune reconstitution (IgM, IgA, and IgG)；Cellular immune reconstitution parameters (CD3⁺, CD4⁺, CD8⁺, and CD19⁺ cell subsets)
Measured: 1 year
Quality of Life Assessment
SF-36 Questionnaire；FACT-BMT Questionnaire
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2024
- Study start15 Jul 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for cGVHDStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiao-Jun Huang, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06364319
- Sponsor's protocol ID
- 2024PHD002-001
- Status last verified
- Jun 2026
- First submitted
- 20 Mar 2024
- Last updated
- 18 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Our plan is to disseminate the findings of this trial via peer-reviewed articles.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Efficacy and Safety of Anti-CD25 rhMAb in the Treatment of Steroid-Refractory Chronic Graft-Versus-Host Disease (cGVHD) of the Liver Following Allogeneic Hematopoietic Stem Cell Transplantation.
- ClinicalTrials.gov ID
- NCT06364319
- Acronym / sponsor ID
- 2024PHD002-001
- Conditions
- cGVHD
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 15 Jul 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 15 Apr 2024 (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.
The study plan aims to include patients who have been diagnosed with steroid-refractory chronic GVHD in the liver following allogeneic hematopoietic stem cell transplantation. After obtaining informed consent, the patients will receive a treatment regimen consisting of the Anti-CD25 rhMAb in combination with prednisone, cyclosporine, and ruxolitinib.The objective is to assess the effectiveness and safety of Anti-CD25 rhMAb in the treatment of severe chronic GVHD affecting the liver.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anti-CD25 rhMAb + traditional therapy | Experimental | Drug: anti-CD25 rhMAb, Drug: Prednisone, Drug: Ruxolitinib, Drug: Cyclosporine |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Age 16 and 65 years
- Received allogeneic hematopoietic stem cell transplantation
- Developed chronic GVHD in the liver after transplantation
- Ineffective prednisone treatment prior to screening
- Received ≤4 lines of systemic therapy prior to screening
Key exclusion criteria (9 listed)
- Elevation of bilirubin, ALT, or alkaline phosphatase due to reasons other than chronic GVHD
- No prior treatment with prednisone
- Overlap syndrome
- Uncontrolled active infection
- Organ failure
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-CD25 rhMAb1 mg/kg/day administered IV day 1, 4, and 8, then weekly for 6 doses. For patients achieving partial remission, an extra dose of Anti-CD25 rhMAb can be given on days 39 and 49. | Drug | Anti-CD25 rhMAb + traditional therapy |
| PrednisoneMaintain pre-screening dose | Drug | Anti-CD25 rhMAb + traditional therapy |
| Ruxolitinib10mg, BID PO | Drug | Anti-CD25 rhMAb + traditional therapy |
| Cyclosporine1.25mg/kg, BID PO/IV, target:150-250ng/ml | Drug | Anti-CD25 rhMAb + traditional therapy |
Primary outcome
overall response rate (ORR)
Time frame: 56 days
ORR is defined as the percentage of complete response (CR) and partial response (PR).
10 secondary outcomes
duration of response（DOR）
Time frame: 1 year
patient-reported outcomes (PRO)
Time frame: 1 year
disease-free survival (DFS)
Time frame: 1 year
failure-free survival (FFS)
Time frame: 1 year
non-relapse mortality (NRM)
Time frame: 1 year
overall survival （OS）
Time frame: 1 year
adverse drug reactions (ADR)
Time frame: 1 year
Best Overall Response Rate (ORR) of Overall cGVHD
Time frame: 1 year
Immune Reconstitution
Time frame: 1 year
Quality of Life Assessment
Time frame: 1 year
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 18 Jun 2026.
- Individual participant dataSharing planned: Undecided. Our plan is to disseminate the findings of this trial via peer-reviewed articles.
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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 4 study testing anti-CD25 rhMAb, Prednisone and Ruxolitinib in people with cGVHD, run by Peking University People's Hospital.
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 6 inclusion and 9 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 18 Jun 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 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?
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?
overall response rate (ORR) (time frame: 56 days). 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 18 Jun 2026.