This clinical trial is for men and women who have been diagnosed with an advanced type of multiple myeloma (MM) and their cancer has returned after taking 3 or more other cancer medications (this is called relapsing) or those medications did not work (this is called refractory). Other study sites are also enrolling patients who have non-Hodgkin’s lymphoma (NHL), but Weill Cornell Medicine is only enrolling participants who have multiple myeloma (MM).
   
This study is being done to determine if the study drug IDP-023 is safe and well-tolerated in subjects with MM, which is a condition with high unmet medical need (there is no satisfactory treatment option currently available). 
   
There are 2 phases to this clinical research study: Phase 1 (dose escalation) and Phase 2 (dose expansion). The goal of Phase 1 is to find the recommended dose of the study drug IDP-023 that can be given alone (referred to as a “monotherapy”), with or without interleukin-2 (IL-2) and in combination with another anti-cancer drug, daratumumab, in subjects with relapsed/refractory MM. The goal of Phase 2 is to learn if the recommended dose of IDP-023 found in Phase 1 with or without IL-2 can help to control advanced MM when given in combination with daratumumab.
   
IDP-023 is not approved by the U.S. Food and Drug Administration (FDA), or commercially available. It is currently being used for research purposes only. IDP-023 is made up of a rare subset of Natural Killer (NK) cells that lack expression of a specific protein called FcεR1 γ. These rare NK cells are thought to have a stronger immune response to cancer cells than regular NK cells. Daratumumab is commercially available for the treatment of MM.
   
Participants will be given IDP-023 via intravenous (IV) infusion through a vein in their hand or arm once or once a week for 3 weeks or once every other day for 3 doses, depending on which part of the study they are in. Participants may be hospitalized for at least four days if they receive IDP-023 once every other day. Participants may be selected to receive another study treatment as well called interleukin 2 (IL-2) as an injection before their dose of IDP-023. Participants may be selected to receive a third study treatment called daratumumab via IV as well as the IL-2 injection before their dose of IDP-023.
   
Participants are expected to be in this research study for approximately 7 years. They will receive study treatment for up to 35 days and then they will visit the clinic approximately monthly for the first year, approximately every 3 months for the next 4 years and then the study staff will contact them for up to 2 years after the study is over to see how they are feeling and the status of their cancer.