Daratumumab for Heart Transplant Rejection
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial is testing a drug combination called daratumumab/hyaluronidase-fihj (DARZALEX Faspro™) to help people waiting for a heart transplant who have high levels of HLA antibodies. The drug works by targeting specific immune cells to lower these antibodies, making it easier to find a compatible donor and reducing the risk of transplant rejection.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
How is the drug Daratumumab different from other treatments for heart transplant rejection?
Daratumumab is unique because it targets CD38, a protein on the surface of certain immune cells, which may help reduce antibody-mediated rejection in heart transplant patients. This mechanism is different from other treatments like bortezomib, which targets plasma cells to reduce donor-specific antibodies.12345
Who Is on the Research Team?
Barry Boilson, MD
Principal Investigator
Mayo Clinic
Are You a Good Fit for This Trial?
This trial is for heart transplant patients or candidates with high HLA antibodies. Participants must have a stable neutrophil count, liver function within certain limits, and adequate kidney function. It's not open to individuals with severe lung conditions like COPD, pregnant or breastfeeding women, those with HIV or hepatitis B/C unless treated successfully, recent major cardiac events, uncontrolled heart issues including arrhythmias, severe asthma in the past 2 years, or prior use of daratumumab.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive daratumumab/hyaluronidase-fihj 1800mg/30000u subcutaneously once a week for 8 weeks for HLA desensitization
Follow-up
Participants are monitored for safety and effectiveness after treatment, including echocardiograms, heart biopsy or MRI, and blood tests
What Are the Treatments Tested in This Trial?
Interventions
- Daratumumab
Daratumumab is already approved in European Union, United States for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Barry A. Boilson
Lead Sponsor
Janssen Biotech, Inc.
Industry Sponsor