Daratumumab for Familial Cerebral Cavernous Malformations: A Single-Arm Safety and Efficacy Study

EARLY_PHASE1Not yet recruitingINTERVENTIONAL
Enrollment

10

Participants

Timeline

Start Date

July 1, 2025

Primary Completion Date

July 1, 2026

Study Completion Date

November 1, 2026

Conditions
Cavernous Malformation, Cerebral
Interventions
DRUG

Daratumumab

Participants receive intravenous daratumumab (16 mg/kg weekly for 8 weeks), diluted in 1000 mL (first dose) or 500 mL (subsequent doses) of saline, with infusion rates escalated stepwise from 50 to 200 mL/h under vital sign monitoring. Premedication (antihistamines/analgesics) is administered 30 minutes prior to each infusion to mitigate reactions.

Trial Locations (1)

Unknown

Beijing Tiantan Hospital, Beijing

All Listed Sponsors
lead

Beijing Tiantan Hospital

OTHER