IDP-023 as a Single Agent and in Combination With Antibody Therapies in Patients With Advanced Hematologic Cancers
NCT ID: NCT06119685
Last Updated: 2025-06-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
128 participants
INTERVENTIONAL
2023-10-25
2029-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Phase 1: Single Agent IDP-023 - Single Dose
NHL or MM patient treated with a single dose of IDP-023 monotherapy
IDP-023
NK cell therapy
Cyclophosphamide
Lymphodepleting chemotherapy
Fludarabine
Lymphodepleting chemotherapy
Mesna
Chemoprotectant
Phase 1: Single Agent IDP-023 - Multiple Doses
NHL and MM patients treated with multiple doses of IDP-023 monotherapy
IDP-023
NK cell therapy
Cyclophosphamide
Lymphodepleting chemotherapy
Fludarabine
Lymphodepleting chemotherapy
Mesna
Chemoprotectant
Phase 1: Single Agent IDP-023 - Multiple Doses with IL-2
NHL and MM patients treated with multiple doses of IDP-023 monotherapy
IDP-023
NK cell therapy
Interleukin-2
Immune cytokine
Cyclophosphamide
Lymphodepleting chemotherapy
Fludarabine
Lymphodepleting chemotherapy
Mesna
Chemoprotectant
Phase 2: Combination IDP-023 plus rituximab
NHL patients treated with multiple doses of IDP-023 in combination with rituximab
IDP-023
NK cell therapy
Rituximab
Anti-CD20 antibody therapy
Interleukin-2
Immune cytokine
Cyclophosphamide
Lymphodepleting chemotherapy
Fludarabine
Lymphodepleting chemotherapy
Mesna
Chemoprotectant
Phase 2: Combination IDP-023 plus daratumumab
MM patients treated with multiple doses of IDP-023 in combination with daratumumab
IDP-023
NK cell therapy
Daratumumab
Anti-CD38 antibody therapy
Interleukin-2
Immune cytokine
Cyclophosphamide
Lymphodepleting chemotherapy
Fludarabine
Lymphodepleting chemotherapy
Mesna
Chemoprotectant
Phase 2: Combination IDP-023 plus isatuximab
MM patients treated with multiple doses of IDP-023 in combination with isatuximab
IDP-023
NK cell therapy
Interleukin-2
Immune cytokine
Cyclophosphamide
Lymphodepleting chemotherapy
Fludarabine
Lymphodepleting chemotherapy
Mesna
Chemoprotectant
Isatuximab
Anti-CD38 antibody therapy
Interventions
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IDP-023
NK cell therapy
Rituximab
Anti-CD20 antibody therapy
Daratumumab
Anti-CD38 antibody therapy
Interleukin-2
Immune cytokine
Cyclophosphamide
Lymphodepleting chemotherapy
Fludarabine
Lymphodepleting chemotherapy
Mesna
Chemoprotectant
Isatuximab
Anti-CD38 antibody therapy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Indapta Therapeutics, INC.
INDUSTRY
Responsible Party
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Principal Investigators
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Indapta Therapeutics, Inc.
Role: STUDY_DIRECTOR
Indapta Therapeutics, INC.
Locations
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Valkyrie Clinical Trials
Los Angeles, California, United States
Florida Cancer Specialists and Research Institute - Lake Mary Cancer Center
Lake Mary, Florida, United States
Emory University Hospital
Atlanta, Georgia, United States
University of Minnesota
Minneapolis, Minnesota, United States
NYP/Weill Cornell Medical Center
New York, New York, United States
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, United States
University Hospitals Cleveland
Cleveland, Ohio, United States
Providence Cancer Institute Franz Clinic
Portland, Oregon, United States
Rhode Island Hospital
Providence, Rhode Island, United States
SCRI Oncology Partners
Nashville, Tennessee, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
NEXT Oncology Virginia
Fairfax, Virginia, United States
Countries
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Central Contacts
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Facility Contacts
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UH Seidman Cancer Center Cancer Information Service Line
Role: primary
Other Identifiers
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Indapta-Trial-1
Identifier Type: -
Identifier Source: org_study_id
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