NCT04610320

Daratumumab-SC for Highly Sensitized Patients Awaiting Heart Transplantation

A Phase 1 Study of Daratumumab-SC for Reduction of Circulating Antibodies in Patients With High Allosensitization Awaiting Heart Transplantation

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Ronald Witteles · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to test whether Daratumumab-SC, 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-SC 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.

Conditions

• Allosensitization
• Heart Transplant Failure and Rejection

Interventions

Type	Name	Description
DRUG	Daratumumab-SC	\>Daratumumab-SC 1800 mg subcutaneous weekly for 8 doses and then every other week for 2 doses.

Timeline

• Start date: 2021-07-01
• Primary completion: 2024-01-26
• Completion: 2024-01-26
• First posted: 2020-10-30
• Last updated: 2024-03-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study