6 Participants Needed

Daratumumab for Heart Transplant Rejection

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise
Approved in 2 JurisdictionsThis treatment is already approved in other countries

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?

BB

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

Agreement to use one of the birth control methods described in this protocol
Absolute neutrophil count > 1,500
Able to provide informed consent
See 7 more

Exclusion Criteria

I am unable to understand and agree to the study's details.
Living outside the US
Pregnant or breastfeeding
See 12 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive daratumumab/hyaluronidase-fihj 1800mg/30000u subcutaneously once a week for 8 weeks for HLA desensitization

8 weeks
8 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including echocardiograms, heart biopsy or MRI, and blood tests

8 weeks
Several visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Daratumumab
Trial Overview The study tests DARZALEX Faspro™ (daratumumab/hyaluronidase-fihj) for its effectiveness in reducing HLA antibodies in people awaiting heart transplants and those who've received a transplant but are experiencing antibody mediated rejection due to high levels of these antibodies.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: HLA Desensitization GroupExperimental Treatment1 Intervention

Daratumumab is already approved in European Union, United States for the following indications:

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Approved in European Union as Darzalex for:
🇺🇸
Approved in United States as Darzalex for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Barry A. Boilson

Lead Sponsor

Trials
1
Recruited
6+

Janssen Biotech, Inc.

Industry Sponsor

Trials
30
Recruited
18,800+

Citations

Rapid reduction in donor-specific anti-human leukocyte antigen antibodies and reversal of antibody-mediated rejection with bortezomib in pediatric heart transplant patients. [2021]
Induction therapy after cardiac transplantation: a comparison of anti-thymocyte globulin and daclizumab in the prevention of acute rejection. [2018]
Increased negative impact of donor HLA-specific together with non-HLA-specific antibodies on graft outcome. [2023]
Reduction of HLA donor specific antibodies in heart transplant patients treated with proteasome inhibitors for antibody mediated rejection. [2023]
Bortezomib-containing regimen for primary treatment of early antibody-mediated cardiac allograft rejection: a case report. [2015]
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