NCT06398457
Darzalex Faspro (Daratumumab and Hyaluronidase-fihj) Before Standard Desensitization and Allogeneic Peripheral Blood Stem Cell Transplantation in Adult Patients at High-risk for Primary Graft Failure Secondary to Donor Specific Antibodies
Recruiting
EARLY_PHASE1Ages 18+InterventionalTreatmentSidney Kimmel Comprehensive Cancer Center at Johns HopkinsInvestigator-initiated
~8 participants
Updated 2025-09-26 on ClinicalTrials.gov
What's tested:Darzalex Faspro (Daratumumab and hyaluronidase-fihj)JH-DSA Semi-Quant Screen and Response Score
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Efficacy as assessed by percentage of patients with reduced DSA levels
Measured over 2 years
+1 more outcome measured
Conditions
Where it's being run
1 sites across 1 statesMaryland1
Study leadership
- Christian B Gocke, MD, PhD · PRINCIPAL_INVESTIGATOR · Johns Hopkins University
Who to contact
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What this trial measures
- Efficacy as assessed by percentage of patients with reduced DSA levels2 years
Efficacy as assessed by the percentage of patients with DSA levels that are reduced to a level permissible for RIC alloHSCT with DSA strength of II or less and at least a 10% decrease in MFI from the baseline as determined by the JH-DSA Response Score.
- Safety as assessed by proportion of patients with grade 3 or higher toxicities2 years
Proportion of patients with Grade 3 or higher toxicities attributable to daratumumab for one cycle of Darzalex Faspro