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IDP-023 as a Single Agent and in Combination With Antibody Therapies in Patients With Advanced Hematologic Cancers
Trial Status: active
This is an open label, Phase 1/2, first-in-human, multiple ascending dose, and
dose-expansion study of IDP-023 administered as a single agent and in combination with or
without interleukin-2 (IL-2), and with or without isatuximab, daratumumab or rituximab to
evaluate the safety, tolerability and preliminary antitumor activity in patients with
advanced hematologic cancers.
Inclusion Criteria
For MM patients: Documented diagnosis of MM requiring systemic therapy and relapsed and/or refractory (R/R) disease after ≥ 3 prior lines of therapy.
For NHL patients: R/R disease and failed ≥ 2 lines of systemic chemotherapy.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Life expectancy of greater than 12 weeks per the Investigator. Key
Exclusion Criteria
Impaired cardiac function or history of clinical significant cardiac disease.
Human immunodeficiency virus (HIV) infection, active hepatitis B infection, or hepatitis C infection.
Active SARS-CoV-2 infection.
Has untreated central nervous system, epidural tumor metastasis, or brain metastasis.
Additional locations may be listed on ClinicalTrials.gov for NCT06119685.
Locations matching your search criteria
United States
Georgia
Atlanta
Emory University Hospital/Winship Cancer Institute
Status: Approved
Name Not Available
Minnesota
Minneapolis
University of Minnesota/Masonic Cancer Center
Status: Temporarily closed to accrual
Name Not Available
North Carolina
Winston-Salem
Wake Forest University Health Sciences
Status: Active
Name Not Available
Texas
Houston
M D Anderson Cancer Center
Status: Active
Name Not Available
IDP-023 is an off-the-shelf, allogeneic cell product made of "natural killer" cells, also
called NK cells. White blood cells are part of the immune system and NK cells are a type
of white blood cell that are known to kill cancer cells.
This is an open label, Phase 1/2, first-in-human, multiple ascending dose, and
dose-expansion study of IDP-023 administered as a single agent and in combination with or
without interleukin-2 (IL-2), and with or without isatuximab, daratumumab or rituximab to
evaluate the safety, tolerability, and preliminary antitumor activity in patients with
relapsed and/or refractory advanced multiple myeloma (MM) or non-Hodgkin's lymphoma
(NHL), respectively.
The study is divided into a phase 1 dose escalation phase and a phase 2 expansion phase.
Phase 1 (Escalation Phase): The primary objectives of Phase 1 are to define the safety of
different IDP-023 containing regimens and to define the recommended regimen and Phase 2
doses (RP2D) of IDP-023.
Phase 2 (Expansion Phase): The objective of the Phase 2 expansion cohort is to evaluate
the safety and efficacy of IDP-023 in advanced MM in combination with isatuximab or
daratumumab and advanced NHL in combination with rituximab.
