The purpose of this study is to test whether Daratumumab-SC, 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-SC 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
8
\>Daratumumab-SC 1800 mg subcutaneous weekly for 8 doses and then every other week for 2 doses.
Stanford Health Care
Stanford, California, United States
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.
Will assess the difference in PRA percentage (defined based on those HLA antibodies which have a mean fluorescence intensity \[MFI\] \>3000) at baseline versus Week 12.
Time frame: Baseline and Week 12 (or the last measurement prior to heart transplantation, whichever is earlier).
Percent MFI change for each individual preformed HLA antibody at Week 6.
Will measure the percent change in the MFI of each circulating preformed HLA antibody from baseline to Week 6 or the time of heart transplantation (whichever is earlier).
Time frame: Baseline and Week 6 (or the last measurement prior to heart transplantation, whichever is earlier).
Percent MFI change for each individual preformed HLA antibody at Week 12.
Will measure the percent change in the MFI of each circulating preformed HLA antibody from baseline to Week 12 or the time of heart transplantation (whichever is earlier).
Time frame: Baseline and Week 12 (or the last measurement prior to heart transplantation, whichever is earlier).
Percent MFI change for each individual preformed HLA antibody at Week 15.
Will measure the percent change in the MFI of each circulating preformed HLA antibody from baseline to Week 15 or the time of heart transplantation (whichever is earlier).
Time frame: Baseline and Week 15 (or the last measurement prior to heart transplantation, whichever is earlier).
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.
Will assess the difference in PRA percentage (defined based on those HLA antibodies which have a mean fluorescence intensity \[MFI\] \>3000) at baseline versus Week 6.
Time frame: Baseline and Week 6 (or the last measurement prior to heart transplantation, whichever is earlier).
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