Immune ThrombocytopeniaPhase 2NCT07362238
Daratumumab Versus Rituximab in the Management of Pediatric Primary Immune Thrombocytopenia (ITP)
A Phase 2 study testing Rituximab and Daratumumab in people with Immune Thrombocytopenia and Treatment, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
Trial summary
This randomized, open-label study aim to compare the efficacy and safety of Daratumumab (anti-CD38 monoclonal antibody) with Rituximab in pediatric ITP patients.This study will be conducted in pediatric ITP patients who had not responded to or had relapsed after previous glucocorticoid treatment. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Immune Thrombocytopenia, Treatment
- What is being tested?
- Rituximab and Daratumumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteChina
- Study dates
- Mar 2026to Mar 2028
- 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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age ≥6，<18 years, male or female.
- Before enrollment, the subjects have been clinically diagnosed with primary immune thrombocytopenia for no less than three months according to the American Society of Hematology guidelines 2011 Evidence-Based Practice Guideline (Neunert et al. 2011) or the International Consensus Report for the Investigation and Management of Primary Immune Thrombocytopenia (Provan et al. 2010), as applicable locally.
- Patients have failed glucocorticoid therapy (either due to inefficacy, efficacy could not be maintained, or relapse). Patients were required to have a response history (PLT≥50×10^9/L) to standard first-line treatment of ITP (glucocorticoid and/or intravenous immunoglobulin).
- Subjects with a platelet count of <30×10^9/L within the 24 hours prior to the first dose of the study drug; The mean platelet count of at least two separate assessments (at least 1 week apart) <30×10^9/L during the screening visit, and no platelet count > 35×10^9/L.
- ECOG performance status score of ≤2.
- Enrollment of subjects receiving maintenance therapy with a stable dosage is permitted, including glucocorticoids (≤0.5 mg/kg of prednisone or equivalent) or TPO receptor agonists. However, at the time of enrollment, subjects are restricted to using only one concomitant medication with a stable dose, and the concomitant medication must have been stable for a minimum of 4 weeks prior to the initial infusion of the study drug.
- Subjects and the legal guardian comprehensively understand and can adhere to the study protocol requirements and willingly signed the informed consent form.
Who cannot join
- Subjects with a history of using CD20 monoclonal antibody or CD38 monoclonal antibody.
- Subjects who are diagnosed with autoimmune hemolytic anemia or various secondary thrombocytopenic disorders.
- Subjects with history of any thrombotic or embolic events or extensive and severe bleeding, such as hemoptysis, major upper gastrointestinal bleeding, intracranial hemorrhage, or the presence of sepsis or other irregular bleeding within the 12 months preceding the initiation of the first dose of study drug.
- Subjects who have participated in any other investigational drug studies (including vaccine studies) or been exposed to other investigational drugs within the first 4 weeks or 5 half-lives (whichever was longer) prior to the first dose of study drug.
- Subjects who have used anticoagulants or any agents with antiplatelet effects, such as aspirin, within 3 weeks prior to the first dose of study drug.
- Subjects who have received emergency treatment for ITP (e.g., methylprednisolone, platelet transfusion, intravenous immunoglobulin infusion, or thrombopoietin receptor agonist therapy) within 2 weeks prior to the first dose of study drug.
Show all 25Show fewer
- Subjects who have been treated with medications including azathioprine, danazol, dapsone, cyclosporine A, tacrolimus, and sirolimus within 4 weeks prior to the first dose of study drug. Subjects who have receive medications including cyclophosphamide and vindesine within 6 months prior to the first dose of study drug.
- Subjects who have undergone splenectomy within 6 months prior to the first dose of study drug.
- Subjects who have received live vaccines within 4 weeks prior to the first dose of study drug, or plan to receive any live vaccines during the course of the study.
- Subjects who are diagnosed with Myelodysplastic syndromes (MDS); Subjects with a with a history of malignancy within the 5 years prior to screening (excluding completely cured in situ cervical cancer and non-metastatic skin squamous cell carcinoma or basal cell carcinoma).
- Subjects who have undergone allogeneic stem cell transplantation or organ transplantation.
- Subjects with a clinically significant medical history, as perceived by investigators, that will pose risks to subjects' safety during the study or potentially affect the safety or efficacy analyses, includes major clinical histories such as circulatory system abnormalities, endocrine system abnormalities, nervous system diseases, blood system diseases, immune system diseases, mental diseases and metabolic abnormalities and so on. e.g., subjects with acute myocardial infarction, unstable angina pectoris, or severe arrhythmias (multifocal ventricular premature contractions, ventricular tachycardia, or ventricular fibrillation) within the 6 months before screening ; New York Heart Association (NYHA) class III-IV heart failure; subjects who were known to have had moderate or severe persistent asthma or chronic obstructive pulmonary disease within the 5 years prior to screening, or whose condition was currently poorly controlled;
- Subjects with a history of severe recurrent or chronic infections, or acute infections requiring systemic treatment with antibiotics, antiviral drugs, antiparasitic drugs, anti-amoebic drugs, or antifungal drugs within 4 weeks prior to the first dose and during the screening period, or superficial skin infections requiring systemic treatment within one week prior to the first dose of study drug. Notably, after the resolution of the infection, the subject may be re-screened.
- Subjects with a history of known or suspected immunosuppression, including invasive opportunistic infections such as histoplasmosis, listeriosis, coccidioidomycosis, pneumocystis pneumonia, and aspergillosis, even if the infection has resolved; or unusually frequent, recurrent, or prolonged infections (as judged by the investigator).
- Significant laboratory abnormalities during screening included:
- Alanine aminotransferase or aspartate aminotransferase greater than three times the upper limit of normal (ULN).
- Total bilirubin greater than 1.5 times the ULN (note: subjects diagnosed with Gilbert syndrome based on medical records should not be excluded based on this criterion).
- absolute neutrophil count < 1500/mm3.
- hemoglobin < 9g/dL.
- IgG < 500 mg/dL.
- lymphocyte count < 500/mm3.
- Creatinine clearance (CrCl) < 30 mL/min (i.e., CrCl ≥30 mL/min is allowed)
- Positive for HIV antibodies or syphilis antibodies.
- Subjects test positive for Hepatitis B surface antigen (HBsAg) or subjects test positive for hepatitis B core antibody and HBV-DNA (through polymerase chain reaction testing), or subjects test positive for hepatitis C virus antibody and HCV-RNA during the screening period. Subjects with positive hepatitis B core antibody but negative HBV-DNA can be enrolled, with HBV-DNA monitoring every 4 weeks.
- Any other conditions unsuitable for participation in this study, as assessed by the investigator.
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
Chinese Academy of Medical Science and Blood Disease Hospital
Tianjin
Lei Zhang, MD, +8602223608180, zhanglei1@ihcams.ac.cn
Ting Sun, MD, +8602223608185, sunting@ihcams.ac.cn
About this study
Official title: A Randomized, Open-label Study To Compare The Efficacy And Safety Of Daratumumab Versus Rituximab in ITP Patients Who Failed or Relapsed After Glucocorticoid Therapy
This randomized, open-label study aim to compare the efficacy and safety of Daratumumab (anti-CD38 monoclonal antibody) with Rituximab in pediatric ITP patients.This study will be conducted in pediatric ITP patients who had not responded to or had relapsed after previous glucocorticoid treatment.
Read the detailed description
Pediatric Immune thrombocytopenia (ITP) is an organ-specific autoimmune disease, which is characterized by decreased platelet count and skin and mucosal bleeding. Pediatric ITP is a kind of disease with increased platelet destruction and impaired platelet production caused by autoimmunity. Conventional treatment of pediatric ITP includes first-line glucocorticoid and immunoglobulin therapy, second line TPO and TPO receptor agonist, splenectomy and other immunosuppressive treatments (such as rituximab, vincristine, azathioprine, etc.). ITP is one of the most common hemorrhagic diseases. At present, the treatment response of ITP is not good, and a considerable number of patients need drug maintenance treatment, which seriously affects the quality of life of patients and increases the economic burden of patients. Therefore, there is still a lack of effective treatment for pediatric ITP, especially for recurrent and refractory ITP patients, which is one of the problems that have attracted more attention and need to be solved urgently.
The main pathogenesis of ITP is the loss of platelet autoantigen immune tolerance, which leads to abnormal activation of humoral and cellular immunity. It is characterized by antibody mediated platelet destruction and insufficient platelet production by megakaryocytes. The residual long-term autoreactive plasma cells may be a source of therapeutic resistance to autoimmune cytopenia. Antiplatelet specific plasma cells have been detected in the spleen of patients with rituximab refractory ITP. Therefore, the strategy of simply eliminating B cells may not work, because LLPC will continue to produce pathogenic antibodies. In view of this, anti-CD38 monoclonal antibody can eliminate LLPC, thereby profoundly reducing the production of pathogenic antibodies and achieving good efficacy. Some pediatric patients in our center have been treated with this Daratumumab (anti-CD38 monoclonal antibody) in the past, with good efficacy and safety. Therefore, we planned to conduct a clinical study to evaluate the safety and efficacy of Daratumumab (anti-CD38 monoclonal antibody) versus rituximab in relapsed pediatric patients with primary immune thrombocytopenia, in order to provide more treatment options for pediatric patients with ITP.
- Conditions
- Immune Thrombocytopenia, Treatment
- Being tested
- Rituximab, Daratumumab
- Medical subject headings
- Purpura, Thrombocytopenic, Idiopathic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RituximabDrug
All subjects were randomly assigned to group A (active comparator) and group B (experimental). For subjects in group A (active comparator) , rituximab (375mg/m2) was given once.
DaratumumabDrug
All subjects were randomly assigned to group A (active comparator) and group B (experimental). For subjects in group B (experimental), Daratumumab (anti-CD38 monoclonal antibody ) (16mg/kg) was given once a week for eight times.
| Study group | Role | What they receive |
|---|---|---|
| Rituximab | Active comparator | Rituximab (375mg/m2) was given once. Receives: Drug: Rituximab |
| Daratumumab（Anti-CD38 Monoclonal Antibody ） | Experimental | Daratumumab（anti-CD38 monoclonal antibody ）(16mg/kg) was given once a week for eight times Receives: Drug: Daratumumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate at week 12
Overall response rate was defined as either partial response or complete response at week 12. Partial response was characterised by at least two consecutive (≥7 days apart) platelet counts of ≥30 to <100×10^9/L, with a minimum doubling from baseline and no bleeding. Complete response was characterised by at least two consecutive (≥7 days apart) platelet counts of ≥100×10^9/L, with no bleeding.
Measured: 12 weeks
Secondary outcomes (14)
Complete response rate at week 12
Complete response was characterised by at least two consecutive (≥7 days apart) platelet counts of ≥100×10^9/L, with no bleeding at week 12.
Measured: 12 weeks
Partial response rate at week 12
Partial response was characterised by at least two consecutive (≥7 days apart) platelet counts of ≥30 to <100×10^9/L, with a minimum doubling from baseline and no bleeding at week 12.
Measured: 12 weeks
Overall response rate at week24
Overall response rate was defined as either partial response or complete response at week 24. Partial response was characterised by at least two consecutive (≥7 days apart) platelet counts of ≥30 to <100×10^9/L, with a minimum doubling from baseline and no bleeding. Complete response was characterised by at least two consecutive (≥7 days apart) platelet counts of ≥100×10^9/L, with no bleeding.
Measured: 6 months
Overall response rate at week52
Overall response rate was defined as either partial response or complete response at week 52. Partial response was characterised by at least two consecutive (≥7 days apart) platelet counts of ≥30 to <100×10^9/L, with a minimum doubling from baseline and no bleeding. Complete response was characterised by at least two consecutive (≥7 days apart) platelet counts of ≥100×10^9/L, with no bleeding.
Measured: 1 year
Long term sustained platelet count response rate
Long term sustained platelet count response rate was defined as proportion of patients with a platelet count ≥30×10^9/L, with at least doubling from baseline and no bleeding, for at least six of the eight visits between weeks 17 and 24.
Measured: 6 months
Cumulative durations of platelet counts ≥50×10^9/L and ≥30×10^9/L, at least doubling from baseline
Cumulative durations of platelet counts ≥50×10^9/L and ≥30×10^9/L, at least doubling from baseline was defined as time from first two consecutive counts meeting criteria, to first two consecutive counts decreasing to below cut-off
Measured: 1 year
Response at each visit
Response at each visit was defined as either overall response, partial response, or complete response at each visit. Overall response rate was defined as either partial response or complete response. Partial response was characterised by at least two consecutive (≥7 days apart) platelet counts of ≥30 to <100×10^9/L, with a minimum doubling from baseline and no bleeding. Complete response was characterised by at least two consecutive (≥7 days apart) platelet counts of ≥100×10^9/L, with no bleeding.
Measured: 1 year
Platelet counts at each visit
Platelet counts at each visit was defined as the platelet counts at each visit
Measured: 1 year
Time to the first two consecutive platelet counts ≥50×10^9/L
Time to the first two consecutive platelet counts ≥50×10^9/L was defined as time to first two consecutive platelet counts ≥50×10^9/L with at least doubling from baseline
Measured: 1 year
Time to response
Time to response was defined as time to first two consecutive platelet counts ≥30×10^9/L with at least doubling from baseline
Measured: 1 year
Rescue treatment
Proportion of patients receiving rescue drugs at each visit throughout the trial
Measured: 1 year
Concomitant treatment
Changes in concomitant treatment at week12 compared with that at baseline
Measured: 12 weeks
Changes in world health organization (WHO) bleeding scale
Changes in world health organization (WHO) bleeding scale without rescue treatment. Changes of every subject in WHO bleeding score after treatment according to the reported World Health Organization's Bleeding Scale. The WHO Bleeding Scale is a measure of bleeding severity with the following grades: grade 0 = no bleeding, grade 1= petechiae, grade 2= mild blood loss, grade 3 = gross blood loss, and grade 4 = debilitating blood loss.
Measured: 1 year
Adverse events
Incidence, severity, and relationship of treatment emergent adverse events after treatment
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 posted23 Jan 2026
- Study startMar 2026 (estimated)
- Primary completionMar 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune ThrombocytopeniaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 122 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07362238
- Sponsor's protocol ID
- IIT2025105
- Status last verified
- Jan 2026
- First submitted
- 15 Jan 2026
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Researchers qualified can request the dataset, including de-identified individual subject data. Data may be requested from PI from 12 months 36 months after study completion.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label Study To Compare The Efficacy And Safety Of Daratumumab Versus Rituximab in ITP Patients Who Failed or Relapsed After Glucocorticoid Therapy
- ClinicalTrials.gov ID
- NCT07362238
- Acronym / sponsor ID
- IIT2025105
- Conditions
- Immune Thrombocytopenia, Treatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 122 participants (estimated)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Study start
- Mar 2026 (estimated)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 23 Jan 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 randomized, open-label study aim to compare the efficacy and safety of Daratumumab (anti-CD38 monoclonal antibody) with Rituximab in pediatric ITP patients.This study will be conducted in pediatric ITP patients who had not responded to or had relapsed after previous glucocorticoid treatment.
Detailed description
Pediatric Immune thrombocytopenia (ITP) is an organ-specific autoimmune disease, which is characterized by decreased platelet count and skin and mucosal bleeding. Pediatric ITP is a kind of disease with increased platelet destruction and impaired platelet production caused by autoimmunity. Conventional treatment of pediatric ITP includes first-line glucocorticoid and immunoglobulin therapy, second line TPO and TPO receptor agonist, splenectomy and other immunosuppressive treatments (such as rituximab, vincristine, azathioprine, etc.). ITP is one of the most common hemorrhagic diseases. At present, the treatment response of ITP is not good, and a considerable number of patients need drug maintenance treatment, which seriously affects the quality of life of patients and increases the economic burden of patients. Therefore, there is still a lack of effective treatment for pediatric ITP, especially for recurrent and refractory ITP patients, which is one of the problems that have attracted more attention and need to be solved urgently.
The main pathogenesis of ITP is the loss of platelet autoantigen immune tolerance, which leads to abnormal activation of humoral and cellular immunity. It is characterized by antibody mediated platelet destruction and insufficient platelet production by megakaryocytes. The residual long-term autoreactive plasma cells may be a source of therapeutic resistance to autoimmune cytopenia. Antiplatelet specific plasma cells have been detected in the spleen of patients with rituximab refractory ITP. Therefore, the strategy of simply eliminating B cells may not work, because LLPC will continue to produce pathogenic antibodies. In view of this, anti-CD38 monoclonal antibody can eliminate LLPC, thereby profoundly reducing the production of pathogenic antibodies and achieving good efficacy. Some pediatric patients in our center have been treated with this Daratumumab (anti-CD38 monoclonal antibody) in the past, with good efficacy and safety. Therefore, we planned to conduct a clinical study to evaluate the safety and efficacy of Daratumumab (anti-CD38 monoclonal antibody) versus rituximab in relapsed pediatric patients with primary immune thrombocytopenia, in order to provide more treatment options for pediatric patients with ITP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rituximab | Active comparator | Drug: RituximabRituximab (375mg/m2) was given once. |
| Daratumumab（Anti-CD38 Monoclonal Antibody ） | Experimental | Drug: DaratumumabDaratumumab（anti-CD38 monoclonal antibody ）(16mg/kg) was given once a week for eight times |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Age ≥6，<18 years, male or female.
- Before enrollment, the subjects have been clinically diagnosed with primary immune thrombocytopenia for no less than three months according to the American Society of Hematology guidelines 2011 Evidence-Based Practice Guideline (Neunert et al. 2011) or the International Consensus Report for the Investigation and Management of Primary Immune Thrombocytopenia (Provan et al. 2010), as applicable locally.
- Patients have failed glucocorticoid therapy (either due to inefficacy, efficacy could not be maintained, or relapse). Patients were required to have a response history (PLT≥50×10^9/L) to standard first-line treatment of ITP (glucocorticoid and/or intravenous immunoglobulin).
- Subjects with a platelet count of <30×10^9/L within the 24 hours prior to the first dose of the study drug; The mean platelet count of at least two separate assessments (at least 1 week apart) <30×10^9/L during the screening visit, and no platelet count > 35×10^9/L.
- ECOG performance status score of ≤2.
Key exclusion criteria (25 listed)
- Subjects with a history of using CD20 monoclonal antibody or CD38 monoclonal antibody.
- Subjects who are diagnosed with autoimmune hemolytic anemia or various secondary thrombocytopenic disorders.
- Subjects with history of any thrombotic or embolic events or extensive and severe bleeding, such as hemoptysis, major upper gastrointestinal bleeding, intracranial hemorrhage, or the presence of sepsis or other irregular bleeding within the 12 months preceding the initiation of the first dose of study drug.
- Subjects who have participated in any other investigational drug studies (including vaccine studies) or been exposed to other investigational drugs within the first 4 weeks or 5 half-lives (whichever was longer) prior to the first dose of study drug.
- Subjects who have used anticoagulants or any agents with antiplatelet effects, such as aspirin, within 3 weeks prior to the first dose of study drug.
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 |
|---|---|---|
| RituximabAll subjects were randomly assigned to group A (active comparator) and group B (experimental). For subjects in group A (active comparator) , rituximab (375mg/m2) was given once. | Drug | Rituximab |
| DaratumumabAll subjects were randomly assigned to group A (active comparator) and group B (experimental). For subjects in group B (experimental), Daratumumab (anti-CD38 monoclonal antibody ) (16mg/kg) was given once a week for eight times. | Drug | Daratumumab（Anti-CD38 Monoclonal Antibody ） |
Primary outcome
Overall response rate at week 12
Time frame: 12 weeks
Overall response rate was defined as either partial response or complete response at week 12. Partial response was characterised by at least two consecutive (≥7 days apart) platelet counts of ≥30 to <100×10^9/L, with a minimum doubling from baseline and no bleeding. Complete response was characterised by at least two consecutive (≥7 days apart) platelet counts of ≥100×10^9/L, with no bleeding.
14 secondary outcomes
Complete response rate at week 12
Time frame: 12 weeks
Partial response rate at week 12
Time frame: 12 weeks
Overall response rate at week24
Time frame: 6 months
Overall response rate at week52
Time frame: 1 year
Long term sustained platelet count response rate
Time frame: 6 months
Cumulative durations of platelet counts ≥50×10^9/L and ≥30×10^9/L, at least doubling from baseline
Time frame: 1 year
Response at each visit
Time frame: 1 year
Platelet counts at each visit
Time frame: 1 year
Time to the first two consecutive platelet counts ≥50×10^9/L
Time frame: 1 year
Time to response
Time frame: 1 year
Rescue treatment
Time frame: 1 year
Concomitant treatment
Time frame: 12 weeks
Changes in world health organization (WHO) bleeding scale
Time frame: 1 year
Adverse events
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 23 Jan 2026.
- Individual participant dataSharing planned: Yes. Researchers qualified can request the dataset, including de-identified individual subject data. Data may be requested from PI from 12 months 36 months after study completion.
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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 Rituximab and Daratumumab in people with Immune Thrombocytopenia and Treatment, 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 7 inclusion and 25 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 23 Jan 2026. 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 Lei Zhang, MD (+8613502118379, zhanglei1@ihcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate at week 12 (time frame: 12 weeks). 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 23 Jan 2026.