What is the mechanism of action of this treatment?

Common treatments for heart transplant patients often involve immunosuppressive therapies that target specific immune cells to prevent organ rejection. Daratumumab/hyaluronidase-fihj, for example, targets CD38 to deplete plasma cells and reduce HLA antibody levels, which is crucial in preventing antibody-mediated rejection. Other treatments include monoclonal antibodies like rituximab, which targets CD20 on B cells, and immunosuppressive drugs like cyclophosphamide. These therapies are vital for heart transplant patients as they help prevent the immune system from attacking the transplanted heart, thereby improving graft survival and overall patient outcomes.

What side effects are associated with this type of intervention?

Common treatments for heart transplant patients often include immunosuppressive therapies such as monoclonal antibodies (e.g., basiliximab, thymoglobulin) and other agents like corticosteroids and mycophenolate mofetil. Side effects of these treatments can include increased risk of infections, neutropenia, lymphocytopenia, and potential viral reactivations (e.g., herpes zoster). Specifically, treatments targeting CD38, like daratumumab, have been associated with higher rates of neutropenia, lymphocytopenia, and infections such as pneumonia and viral reactivations. These side effects necessitate careful monitoring and management to ensure patient safety.

What prior FDA approvals exist?

FDA approvals for heart transplant treatments have included various immunosuppressive drugs to prevent organ rejection. While specific approvals for drugs targeting CD38 like daratumumab/hyaluronidase-fihj are not detailed, similar treatments often involve monoclonal antibodies and other agents that modulate the immune system. For instance, drugs like rituximab, which targets CD20 on B cells, have been used to manage antibody-mediated rejection in transplant patients. These treatments aim to reduce the levels of harmful antibodies and improve transplant outcomes.

What other types of research exist?

Promising alternatives to Daratumumab/hyaluronidase-fihj for heart transplant patients may include therapies such as rituximab (targets CD20 to deplete B cells), bortezomib (a proteasome inhibitor that depletes plasma cells), and newer agents like belatacept (a costimulation blocker). These therapies are used in various transplant settings to manage antibody levels and could be considered in consultation with a transplant specialist.

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Monoclonal Antibodies

Daratumumab for Heart Transplant Rejection

Phase 2

Waitlist Available

Led By Barry Boilson, MD

Research Sponsored by Barry A. Boilson

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Negative pregnancy test (if woman of childbearing potential)

Be older than 18 years old

Must not have

Inability to give informed consent

History of any lymphoproliferative disorder

Timeline

Screening 3 weeks

Treatment Varies

Follow Up one month post completion

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include immune system reactions such as infusion-related responses and possible impacts on blood cell counts. Organ inflammation could occur given that it targets specific cells involved in the body's immune response.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am not pregnant or have confirmed it with a test.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am unable to understand and agree to the study's details.

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I have had a condition where my lymphocytes grow abnormally.

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I have a history of cancer.

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I have had moderate to severe asthma in the last 2 years.

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I am unable to understand and give consent for treatment.

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I have a history of HIV or hepatitis B/C.

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My lung function is less than half of what is expected for someone my age and size.

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I have a serious heart condition.

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I am on the list for both heart and liver transplants.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ one month post completion

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~one month post completion

This trial's timeline: 3 weeks for screening, Varies for treatment, and one month post completion for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Effect of daratumumab therapy on HLA antibody titers in sensitization (pre-transplant)

Effect of daratumumab therapy on human leukocyte antibody (HLA) titers in resistant antibody mediated rejection (AMR)

Secondary study objectives

Effect of daratumumab on Cardiac Systolic Strain in HLA sensitized patients

Effect of daratumumab on Left Ventricular Filling Pressure Ratio in HLA sensitized patients

Effect of daratumumab on Right Ventricular Systolic Pressure (RVSP) in HLA sensitized patients

+2 more

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: HLA Desensitization GroupExperimental Treatment1 Intervention

Subjects awaiting cardiac transplantation with high levels of circulating Human Leukocyte Antigen (HLA) antibodies will receive daratumumab/hyaluronidase-fihj.

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for heart transplant patients often involve immunosuppressive therapies that target specific immune cells to prevent organ rejection. Daratumumab/hyaluronidase-fihj, for example, targets CD38 to deplete plasma cells and reduce HLA antibody levels, which is crucial in preventing antibody-mediated rejection. Other treatments include monoclonal antibodies like rituximab, which targets CD20 on B cells, and immunosuppressive drugs like cyclophosphamide. These therapies are vital for heart transplant patients as they help prevent the immune system from attacking the transplanted heart, thereby improving graft survival and overall patient outcomes.

T Follicular Helper Cells As a New Target for Immunosuppressive Therapies.Single dose anti-CD4 monoclonal antibody for induction of tolerance to cardiac allograft in high- and low-responder rat strain combinations.