Stopped: Study no longer had funding and therefore was closed before enrollment began.
The purpose of this study is to determine the safety and feasibility of adding isatuximab to standard of care therapies in patients who will receive a lung transplant, but have significant antibodies against the donor (desensitization), or patients who have previously received a lung transplant and develop antibodies against the donor (antibody-mediated rejection, AMR). The study will compare the impact of isatuximab on the recurrence of antibodies after they have been removed from the blood by a process known as plasmapheresis that is standard of care for this condition. The use of isatuximab in lung transplant recipients is investigational, meaning it is not Food and Drug Administration (FDA) approved for use in lung transplant recipients. This study is a pilot study investigating the feasibility and safety of isatuximab in lung transplant patients. Isatuximab is an FDA approved drug indicated for the treatment of multiple myeloma. It may also be useful for transplant recipients with antibodies against the donor because it eliminates the cells that make antibodies.
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Clinical Resolution, as measured by the number of participants with less than 1 episode of Antibody-mediated rejection (AMR)
Timeframe: Day 0 (Visit 1)
Clinical Resolution, as measured by the number of participants with less than 1 episode of Antibody-mediated rejection (AMR)
Timeframe: Day 28 (Visit 5)
Clinical Resolution, as measured by the number of participants with no presence of Donor-specific antibody (DSA)
Timeframe: Day 0 (Visit 1)
Clinical Resolution, as measured by the number of participants with no presence of Donor-specific antibody (DSA)
Timeframe: Day 28 (Visit 5)
Clinical Resolution, as measured by the number of participants with reduction of DSA titer
Timeframe: Day 0 (Visit 1)
Clinical Resolution, as measured by the number of participants with reduction of DSA titer
Timeframe: Day 28 (Visit 5)