Phase 1/2 Study of IDP-023 as a Single Agent and in Combination With Antibody Therapies in Patients With Advanced Hematologic Cancers
Indapta Therapeutics, INC.
Summary
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.
Description
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 r…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 infect…
Interventions
- DrugIDP-023
NK cell therapy
- DrugRituximab
Anti-CD20 antibody therapy
- DrugDaratumumab
Anti-CD38 antibody therapy
- DrugInterleukin-2
Immune cytokine
- DrugCyclophosphamide
Lymphodepleting chemotherapy
- DrugFludarabine
Lymphodepleting chemotherapy
- DrugMesna
Chemoprotectant
Locations (12)
- Valkyrie Clinical TrialsLos Angeles, California
- Florida Cancer Specialists and Research Institute - Lake Mary Cancer CenterLake Mary, Florida
- Emory University HospitalAtlanta, Georgia
- University of MinnesotaMinneapolis, Minnesota
- NYP/Weill Cornell Medical CenterNew York, New York
- Atrium Health Wake Forest BaptistWinston-Salem, North Carolina