drugset / Trial / NCT04088903

Study of Daratumumab for Decreasing Circulating Antibodies in Sensitized Patients Awaiting Heart Transplantation

NCT04088903

Phase 1 Withdrawn Ronald Witteles
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to test whether daratumumab, a drug that eliminates antibody-producing plasma cells, can effectively lower the level of preformed antibodies in patients awaiting heart transplantation. These preformed antibodies limit the number of donor hearts that are compatible for the patients. If daratumumab can effectively remove preformed, donor-specific antibodies, then highly allosensitized patients will have more compatible hearts available to them, potentially decreasing transplant waitlist time and reducing mortality.

Timeline

Start
2021-04-01
Primary completion
2023-04-01
Completion
2023-04-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Daratumumab Monoclonal antibody 2 mg/kg Intravenous
Subject Daratumumab Monoclonal antibody 16 mg/kg Intravenous