RecruitingRecruiting
IDP-023 as a Single Agent and in Combination With Antibody Therapies in Patients With Advanced Hematologic Cancers
NCT06119685 · Indapta Therapeutics, INC.
In plain English
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Official title
Phase 1/2 Study of IDP-023 as a Single Agent and in Combination With Antibody Therapies in Patients With Advanced Hematologic Cancers
About this study
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.
Eligibility criteria
Key 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.
Study design
Enrollment target: 128 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2023-10-25
Estimated completion: 2029-12-31
Last updated: 2025-06-03
Interventions
Drug: IDP-023Drug: RituximabDrug: DaratumumabDrug: Interleukin-2Drug: CyclophosphamideDrug: FludarabineDrug: MesnaDrug: Isatuximab
Primary outcomes
- • Incidence of adverse events (AEs) and serious adverse events (SAEs) - (Phase 1) (1 year)
- • Incidence of dose-limiting toxicities (DLTs) of IDP-023 Monotherapy - (Phase 1) (up to 21 days)
- • Nature of dose-limiting toxicities (DLTs) of IDP-023 Monotherapy - (Phase 1) (up to 21 days)
Sponsor
Indapta Therapeutics, INC. · industry
Contacts & investigators
ContactIndapta Therapeutics, Inc. · contact · TRIALS@INDAPTA.COM
InvestigatorIndapta Therapeutics, Inc. · study_director, Indapta Therapeutics, INC.
All locations (12)
Valkyrie Clinical TrialsRecruiting
Los Angeles, California, United States
Florida Cancer Specialists and Research Institute - Lake Mary Cancer CenterWithdrawn
Lake Mary, Florida, United States
Emory University HospitalRecruiting
Atlanta, Georgia, United States
University of MinnesotaRecruiting
Minneapolis, Minnesota, United States
NYP/Weill Cornell Medical CenterWithdrawn
New York, New York, United States
Atrium Health Wake Forest BaptistRecruiting
Winston-Salem, North Carolina, United States
University Hospitals ClevelandRecruiting
Cleveland, Ohio, United States
Providence Cancer Institute Franz ClinicWithdrawn
Portland, Oregon, United States
Rhode Island HospitalRecruiting
Providence, Rhode Island, United States
SCRI Oncology PartnersRecruiting
Nashville, Tennessee, United States
University of Texas MD Anderson Cancer CenterRecruiting
Houston, Texas, United States
NEXT Oncology VirginiaRecruiting
Fairfax, Virginia, United States