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

Sponsor
Institute of Hematology & Blood Diseases Hospital, China
Study ID
NCT07063199
Phase
PHASE2
Status
Recruiting
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Conditions

  • Immune Thrombocytopenia
  • Treatment

Eligibility Criteria

Sex
ALL
Age
60 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Daratumumab Injection — DRUG
    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.

Study Details

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

Key Dates

Start date
Aug 31, 2025
Status verified
Jun 2025
Primary completion
Aug 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Intervention (Daratumumab)
    30 enrolled subjects: once a week x 4 doses Daratumumab Injection

Primary Outcome Measure

Adverse events of Anti-CD38 antibody treatment [ Time Frame: 24 weeks ]

Central Contacts

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