New hope for kids with Hard-to-Treat blood disorder
NCT ID NCT06168851
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests an experimental drug called Anti-CD38 antibody in 60 children aged 6 and older who have immune thrombocytopenia (ITP), a condition where the immune system destroys platelets, causing bleeding risks. The participants have not responded well to standard treatments. The goal is to see if the drug can safely raise platelet counts to safer levels within 8 weeks.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2023
- Expected to finish
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Dec 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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6 to 17 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age 6 years and above, male or female * Conform to the diagnostic criteria of immune Thrombocytopenia (ITP) * Diagnosis of ITP ≥3 months, and with a platelet count of \<30 X 10\^9/L measured within 2 days prior to inclusion * Failure to achieve response or relapse after corticosteroid therapy, and at least one second-line therapy including rituximab or TPORAs. * The previous emergency treatment of ITP (e.g. methylprednisolone, platelet transfusion, IVIG transfusion) must be completed at least 2 weeks before the first administration * Signed and dated written informed consent * With normal hepatic and renal functions * ECOG physical state score ≤ 2 points * Cardiac function of the New York Society of Cardiac Function ≤ 2 * Patients receiving maintenance treatment (including corticosteroids (less than or equal to 0.5mg/kg prednisone), TPO receptor agonists, etc.) must have a stable dose at least 4 weeks before the first administration, and azathioprine, danazol, cyclosporin A, tacrolimus, sirolimus, etc. must be stopped at least 4 weeks before the first administration; The end of rituximab treatment was\>3 months;More than 6 months after splenectomy. March 26,2024 After approval by the Ethics Committee,age of subjects has been modified to 6 years and above upon enrollment. Approval Number: IIT2023072-EC-2. Exclusion Criteria: * Allergy to daratumumab or its excipients, or prior treatment with daratumumab that was refractory or achieved a response lasting \<6 months; * Uncontrollable primary diseases of important organs, such as malignant tumors, liver failure, heart failure, renal failure and other diseases; * HIV positive; * Accompanied by uncontrollable active infection, including hepatitis B, hepatitis C, cytomegalovirus, EB virus and syphilis positive; * Accompanied by extensive and severe bleeding, such as hemoptysis, upper gastrointestinal hemorrhage, intracranial hemorrhage, etc.; * At present, there are heart diseases, arrhythmias that need treatment or hypertension that researchers judge is poorly controlled; * Patients with thrombotic diseases such as pulmonary embolism, thrombosis and atherosclerosis; * Those who have received allogeneic stem cell transplantation or organ transplantation in the past; * Patients with mental disorders who cannot normally obtain informed consent and conduct trials and follow-up; * Patients whose toxic symptoms caused by pre-trial treatment have not disappeared; * Other serious diseases that may limit the subject's participation in this test (such as diabetes; Severe cardiac insufficiency; Myocardial obstruction or unstable arrhythmia or unstable angina pectoris in recent 6 months; Gastric ulcer, etc.); * Patients with septicemia or other irregular severe bleeding; * Patients taking antiplatelet drugs at the same time; * Pregnant women, suspected pregnancies (positive pregnancy test for human chorionic gonadotropin in urine at screening) and lactating patients.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Chinese Academy of Medical Science and Blood Disease Hospital
RECRUITINGTianjin, Tianjin Municipality, 300020, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can viral markers predict who survives hepatitis b liver failure?
- Real-World data may reveal which ITP treatments work best
- A diet tweak may boost platelets in a bleeding disorder
- What Trade-Offs are ITP patients willing to make for better treatment?
- Could a single shot replace daily HIV pills?
- Can a new drug calm the immune System's attack on blood cells?