[logo] HealthTree Foundation
search more_vert
close
person Sign In / Create Account
arrow_back

Go back to trials list

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


Interested in joining this trial?

Our dedicated patient navigators are here to guide you through the validation and enrollment process with ease.

newsletter icon

Get the latest thought leadership on your Lymphoma delivered straight to your inbox

Subscribe to the weekly newsletter for news, stories, clinical trial updates, and helpful resources and events with cancer experts.