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Monoclonal Antibodies

Daratumumab for Heart Transplant Waitlist Patients

Phase 1
Waitlist Available
Led By Ronald M Witteles, MD
Research Sponsored by Ronald Witteles
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and week 15 (or the last measurement prior to heart transplantation, whichever is earlier).
Awards & highlights

Study Summary

This trial is testing whether a drug that eliminates antibody-producing plasma cells can lower the level of preformed antibodies in patients awaiting heart transplantation. If successful, this could decrease transplant waitlist time and reduce mortality.

Who is the study for?
This trial is for heart transplant waitlisted patients with high antibody levels (PRA of 50% or more), who can consent and use birth control. Excluded are those with active infections, pregnancy, breastfeeding, severe lung conditions like COPD, certain viral infections (HIV, hepatitis B/C unless treated), myeloma or amyloidosis history, recent other desensitization treatments or blood transfusions.Check my eligibility
What is being tested?
The study tests Daratumumab-SC's ability to reduce preformed antibodies in highly sensitized patients awaiting a heart transplant. The goal is to increase the number of compatible donor hearts available and decrease waiting times and mortality by eliminating antibody-producing cells.See study design
What are the potential side effects?
While not explicitly listed here, potential side effects may include reactions related to immune system suppression such as increased risk of infection. Specific side effects would be detailed in patient information based on known profiles of drugs like Daratumumab.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and week 15 (or the last measurement prior to heart transplantation, whichever is earlier).
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and week 15 (or the last measurement prior to heart transplantation, whichever is earlier). for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in the level of preformed HLA antibodies before and after Daratumumab-SC treatment, based on the absolute difference in PRA levels before and after treatment.
Secondary outcome measures
Change in the level of preformed HLA antibodies before and after Daratumumab-SC treatment, based on the absolute difference in PRA levels at baseline and Week 6.
HLA Antigens
Percent MFI change for each individual preformed HLA antibody at Week 15.
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Daratumumab-SC InjectionExperimental Treatment1 Intervention
Participants will receive a subcutaneous dose of Daratumumab-SC (1800 mg) weekly for 8 doses and then every other week for 2 doses. Participants will undergo laboratory testing, including for circulating antibodies, at baseline, prior to each infusion session, and at the end of the study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Daratumumab
FDA approved

Find a Location

Who is running the clinical trial?

Ronald WittelesLead Sponsor
1 Previous Clinical Trials
1 Trials studying Allosensitization
Ronald M Witteles, MDPrincipal InvestigatorStanford University
1 Previous Clinical Trials
1 Trials studying Allosensitization

Media Library

Daratumumab-SC (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04610320 — Phase 1
Allosensitization Research Study Groups: Daratumumab-SC Injection
Allosensitization Clinical Trial 2023: Daratumumab-SC Highlights & Side Effects. Trial Name: NCT04610320 — Phase 1
Daratumumab-SC (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04610320 — Phase 1

Frequently Asked Questions

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

Are there any opportunities for volunteers to join this clinical investigation?

"Affirmative, the details available on clinicaltrials.gov reveal that this medical trial is currently recruiting patients. It was initially uploaded to the website on July 1st 2021 and last modified on September 20th 2021. The goal is to enroll 12 individuals from a single location."

Answered by AI

Is Daratumumab-SC an efficacious and innocuous treatment option?

"The safety of Daratumumab-SC is estimated to be a 1 due to the preliminary nature of this Phase 1 clinical trial, meaning there has not been adequate data collection on efficacy or safety."

Answered by AI

Has Daratumumab-SC been applied in any other medical experiments?

"Currently, 140 studies exploring Daratumumab-SC are in operation. Of these active trials, 26 have reached Phase 3 of the research process. While much of this trial data is originating from Harrison, New york, an extensive total of 5564 medical centres around the world are taking part in such experiments."

Answered by AI

What is the scale of the participants in this trial?

"Affirmative. Clinicaltrials.gov's information demonstrates that this medical experiment, initially announced on July 1st 2021, is currently recruiting patients. 12 subjects must be recruited from a single site for the trial to take place successfully."

Answered by AI

What maladies has Daratumumab-SC been demonstrated to remediate?

"Daratumumab-SC is a highly efficacious treatment for biological response modifiers, and can also be used to alleviate refractory multiple myeloma, relapse or refractory multiple myeloma, as well as cell transplant related issues."

Answered by AI

Is the age limit for this medical trial set at fifty-five or older?

"Patients who are 18 years or older, but younger than 75 can apply to take part in this medical trial."

Answered by AI

Which demographics are eligible to participate in this clinical experiment?

"Criteria for enrolment involves both age restrictions (18-75) and an allosensitization diagnosis. As of now, a dozen candidates have been admitted into the trial."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Daratumumab-SC for Highly Sensitized Patients Awaiting Heart Transplantation
Ronald Witteles 2021. "Daratumumab-SC for Highly Sensitized Patients Awaiting Heart Transplantation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04610320.
~2 spots leftby Apr 2025
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