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Anti-CD38 Antibody Treating Children With Primary Immune Thrombocytopenia (ITP)

NCT06838962 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-08-05

No results posted yet for this study

Summary

To evaluate the safety and efficacy of Anti-CD38 Antibody in the treatment of primary immune thrombocytopenia in patients who have failed first-line treatment.

Conditions

Interventions

DRUG

Daratumumab Injection

intravenous Daratumumab administration This study adopts a prospective, single arm, open design method. Thirty subjects were enrolled in the study and were treated with CD38 monoclonal antibody (Daratumumab 16mg/kg/w) for 4 weeks. The first stage is the main research stage (d1-w4), which is the core treatment period. The subjects will receive intravenous infusion of 16mg/kg Daratumumab once a week for 4 weeks to observe the safety and efficacy during treatment. The second stage (w5-w24) is the stage of withdrawal from the visit, mainly to observe the safety and continuous efficacy of Daratumumab after treatment.

Sponsors & Collaborators

  • Institute of Hematology & Blood Diseases Hospital, China

    lead OTHER

Principal Investigators

  • Lei Zhang, MD · Chinese Academy of Medical Science and Blood Disease Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-01
Primary Completion
2026-08-31
Completion
2026-08-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06838962 on ClinicalTrials.gov