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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


Description

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 daratumumab or rituximab to evaluate the safety, tolerability and preliminary antitumor activity in patients with advanced hematologic cancers.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 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-Ho

Trial Eligibility

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 Info

Organization

Indapta Therapeutics, INC.


Primary Outcome

Incidence of adverse events (AEs) and serious adverse events (SAEs) - (Phase 1)


Outcome Timeframe 1 year

NCTID NCT06119685

Phases PHASE1,PHASE2

Primary Purpose TREATMENT

Start Date 2023-10-25

Completion Date 2025-12-30

Enrollment Target 128

Interventions

DRUG IDP-023

DRUG Rituximab

DRUG Daratumumab

DRUG Interleukin-2

DRUG Cyclophosphamide

DRUG Fludarabine

DRUG Mesna

Locations Recruiting

Valkyrie Clinical Trials

United States, California, Los Angeles


Stanford University

United States, California, Stanford


Florida Cancer Specialists and Research Institute - Lake Mary Cancer Center

United States, Florida, Lake Mary


Emory University Hospital

United States, Georgia, Atlanta


University of Minnesota

United States, Minnesota, Minneapolis


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