Overview

Anti-CD38 Antibody Treating Pediatric Primary Immune Thrombocytopenia (ITP)

Status:
Recruiting
Trial end date:
2025-12-01
Target enrollment:
0
Participant gender:
All
Summary
To evaluate the safety and efficacy of Anti-CD38 Antibody in the treatment of pediatric primary immune thrombocytopenia in patients who have not responded adequately or relapsed after first-line treatment and at least one second-line therapy including Anti-CD20 Antibody and/or TPO-RA, or those in whom no other second-line treatment options are suitable.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Institute of Hematology & Blood Diseases Hospital, China
Treatments:
Antibodies
Criteria
Inclusion Criteria:

- Age 12-17 years old, 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 109/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.

Exclusion Criteria:

- Received any treatment of anti-CD38 antibody drug

- 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.