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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured every 2 weeks while on treatment and than at one month post completion
Awards & highlights

Study Summary

This trial is testing a drug to see if it can lower HLA antibodies in people waiting for a heart transplant or who have developed antibody-mediated rejection after a transplant.

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.Check my eligibility
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.See study design
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
Select...
I am not pregnant or have confirmed it with a test.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
Effect of daratumumab on Cardiac Systolic Strain in AMR
Effect of daratumumab on Cardiac Systolic Strain in HLA sensitized patients
Effect of daratumumab on Left Ventricular Filling Pressure Ratio in AMR
+9 more

Trial Design

2Treatment 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.
Group II: AMR Treatment GroupExperimental Treatment1 Intervention
Subjects with antibody mediated cardiac allograft rejection (AMR) and cardiac allograft dysfunction will receive daratumumab/hyaluronidase-fihj.

Find a Location

Who is running the clinical trial?

Janssen Biotech, Inc.Industry Sponsor
29 Previous Clinical Trials
18,803 Total Patients Enrolled
Barry A. BoilsonLead Sponsor
Barry Boilson, MDPrincipal InvestigatorMayo Clinic

Media Library

Daratumumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05300451 — Phase 2
Antibody Mediated Rejection Research Study Groups: AMR Treatment Group, HLA Desensitization Group
Antibody Mediated Rejection Clinical Trial 2023: Daratumumab Highlights & Side Effects. Trial Name: NCT05300451 — Phase 2
Daratumumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05300451 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the protocol for this experiment encompass elderly participants?

"In agreement with this medical trial's standards, the age range for potential enrolment is 18 years old to 80."

Answered by AI

Are there any vacancies remaining in this research program?

"As per the information presented on clinicaltrials.gov, recruitment for this particular trial has closed as of April 11th 2022. The study was initially made available to participants on March 31st 2022 and is no longer recruiting patients; however there are 19 other medical trials searching for volunteers at present."

Answered by AI

What is the ultimate aim of this clinical research?

"The principal objective of this 16-week experiment is to determine the effect of daratumumab therapy on Human Leukocyte Antibody (HLA) titers in resistant Antibody Mediated Rejection (AMR). Secondary assessments include changes in Cardiac Systolic Strain as observed by echocardiogram, Right Ventricular Systolic Pressure (RVSP) when measured with an approximate pulmonary arterial systole pressure device, and similar evaluations for HLA sensitized patients."

Answered by AI

Are there any potential adverse effects associated with the usage of Daratumumab and hyaluronidase-fihj?

"After careful evaluation, our team at Power assigned Daratumumab and hyaluronidase-fihj a score of 2 as there is evidence to suggest it's safe but none that confirms its efficacy."

Answered by AI

What criteria must potential participants meet in order to be accepted into this clinical trial?

"To be considered for this study, prospective participants must possess the antibodies associated with rejection and fall within the age range of 18 to 80. The medical trial is hoping to enrol 6 people in total."

Answered by AI
~2 spots leftby Mar 2025