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.12 个研究点分布在 1 个国家目标入组 128 人开始时间: 2023年10月25日最近更新: 2025年6月3日

适应症

干预措施

试验速览

阶段: 1 期
状态: 招募中
发起方: Indapta Therapeutics, INC.
入组人数: 128
试验地点: 12
主要终点: Incidence of adverse events (AEs) and serious adverse events (SAEs) - (Phase 1)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Parallel
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•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
•Life expectancy of greater than 12 weeks per the Investigator.

排除标准

•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.

研究组 & 干预措施

Phase 1: Single Agent IDP-023 - Single Dose

Experimental

NHL or MM patient treated with a single dose of IDP-023 monotherapy

干预措施: IDP-023 (Drug)

Phase 1: Single Agent IDP-023 - Single Dose

Experimental

NHL or MM patient treated with a single dose of IDP-023 monotherapy

干预措施: Cyclophosphamide (Drug)

Phase 1: Single Agent IDP-023 - Single Dose

Experimental

NHL or MM patient treated with a single dose of IDP-023 monotherapy

干预措施: Fludarabine (Drug)

Phase 1: Single Agent IDP-023 - Single Dose

Experimental

NHL or MM patient treated with a single dose of IDP-023 monotherapy

干预措施: Mesna (Drug)