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Phase 1/2 Study of IDP-023 as a Single Agent and in Combination with Antibody Therapies in Patients with Advanced Hematologic Cancers

Clinical Trial Details

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.

Key Eligibility: 
  1. Adults with documented diagnosis of multiple myeloma (MM) requiring systemic therapy.
  2. Relapsed/Refractory (R/R) disease after 3 or more prior lines of therapy.

Detailed eligibility reviewed when participant contacts the study team.

Study contact by location

Upper East Side - Manhattan


Natalie Agudo, RN

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:






Open to Enrollment

Age Group