Study of Daratumumab for Decreasing Circulating Antibodies in Sensitized Patients Awaiting Heart Transplantation

Sponsor
Ronald Witteles
Study ID
NCT04088903
Phase
PHASE1
Status
Withdrawn

Conditions

  • Allosensitization
  • Heart Transplant Failure and Rejection

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Daratumumab — DRUG
    \>Daratumumab 16 mg/kg intravenous weekly for 8 weeks and then every other week for 2 doses.

Study Details

The purpose of this study is to test whether daratumumab, a drug that eliminates antibody-producing plasma cells, can effectively lower the level of preformed antibodies in patients awaiting heart transplantation. These preformed antibodies limit the number of donor hearts that are compatible for the patients. If daratumumab can effectively remove preformed, donor-specific antibodies, then highly allosensitized patients will have more compatible hearts available to them, potentially decreasing transplant waitlist time and reducing mortality.

Key Dates

Start date
Apr 1, 2021
Status verified
Oct 2020
Primary completion
Apr 1, 2023
Completion
Apr 1, 2023

Study Design

Enrollment
0 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Daratumumab infusion
    * Participants will receive an intravenous infusion of daratumumab weekly for 8 doses and then every other week for 2 doses. * For this dose-escalation study, the initial patients will receive a 2 mg/kg dose of daratumumab. In subsequent patients, the dose will be uptitrated to 16 mg/kg as tolerated. * Participants will undergo laboratory testing, including for circulating antibodies, at baseline, prior to each infusion session, and at the end of the study.

Primary Outcome Measure

Change in the number of individual preformed HLA antibodies before and after daratumumab treatment. [ Time Frame: Baseline and Week 12 (or the last measurement prior to heart transplantation, whichever is earlier). ]

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