NCT06119685

IDP-023 as a Single Agent and in Combination With Antibody Therapies in Patients With Advanced Hematologic Cancers

Phase 1/2 Study of IDP-023 as a Single Agent and in Combination With Antibody Therapies in Patients With Advanced Hematologic Cancers

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 128 (estimated)
• Sponsor: Indapta Therapeutics, INC. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 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

• NHL
• Multiple Myeloma
• Blood Cancer
• Refractory Non-Hodgkin Lymphoma
• Relapsed Non-Hodgkin Lymphoma
• Refractory Multiple Myeloma
• Relapsed Multiple Myeloma

Interventions

Type	Name	Description
DRUG	IDP-023	NK cell therapy
DRUG	Rituximab	Anti-CD20 antibody therapy
DRUG	Daratumumab	Anti-CD38 antibody therapy
DRUG	Interleukin-2	Immune cytokine
DRUG	Cyclophosphamide	Lymphodepleting chemotherapy
DRUG	Fludarabine	Lymphodepleting chemotherapy
DRUG	Mesna	Chemoprotectant
DRUG	Isatuximab	Anti-CD38 antibody therapy

Timeline

• Start date: 2023-10-25
• Primary completion: 2025-12-30
• Completion: 2029-12-31
• First posted: 2023-11-07
• Last updated: 2025-06-03

Locations

12 sites across 1 country: United States

Regulatory

• FDA-regulated drug study