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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат IDP-023
  NK cell therapy
• Препарат Rituximab
  Anti-CD20 antibody therapy
• Препарат Daratumumab
  Anti-CD38 antibody therapy
• Препарат Interleukin-2
  Immune cytokine
• Препарат Cyclophosphamide
  Lymphodepleting chemotherapy
• Препарат Fludarabine
  Lymphodepleting chemotherapy
• Препарат Mesna
  Chemoprotectant
• Препарат Isatuximab
  Anti-CD38 antibody therapy

Первичные конечные точки

• Incidence of adverse events (AEs) and serious adverse events (SAEs) - (Phase 1) [Срок оценки: 1 year]
• Incidence of dose-limiting toxicities (DLTs) of IDP-023 Monotherapy - (Phase 1) [Срок оценки: up to 21 days]
• Nature of dose-limiting toxicities (DLTs) of IDP-023 Monotherapy - (Phase 1) [Срок оценки: up to 21 days]
• Incidence of dose-limiting toxicities (DLTs) of IDP-023 in combination with Isatuximab, Daratumumab or Rituximab - (Phase 1) [Срок оценки: up to 35 days]
• Nature of dose-limiting toxicities (DLTs) of IDP-023 in combination with Isatuximab, Daratumumab or Rituximab - (Phase 1) [Срок оценки: up to 35 days]
• Maximum tolerable dose (MTD) or a tolerated dose below MTD - (Phase 1) [Срок оценки: 1 year]
• For MM: Anti-tumor activity by objective response rate (ORR), complete response (CR), stringent complete response (sCR), very good partial response (VGPR), and partial response (PR) - (Phase 2) [Срок оценки: 2 years]
• For NHL: Anti-tumor activity by objective response rate (ORR) - (Phase 2) [Срок оценки: 2 years]

Вторичные конечные точки (5)

• PK (Cmax) of IDP-023 - (Phase 1/2) [Срок оценки: 2 years]
• PK (AUC) of IDP-023 - (Phase 1/2) [Срок оценки: 2 years]
• For MM: Anti-tumor activity by objective response rate (ORR), complete response (CR), stringent complete response (sCR), very good partial response (VGPR), and partial response (PR) - (Phase 1) [Срок оценки: 1 year]
• For NHL: Anti-tumor activity by objective response rate (ORR) - (Phase 1) [Срок оценки: 1 year]
• Incidence of adverse events (AEs) and serious adverse events (SAEs) - (Phase 2) [Срок оценки: 2 years]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 12 центров

• Valkyrie Clinical Trials — Los Angeles
• Florida Cancer Specialists and Research Institute - Lake Mary Cancer Center — Lake Mary
• Emory University Hospital — Atlanta
• University of Minnesota — Minneapolis
• NYP/Weill Cornell Medical Center — New York
• Atrium Health Wake Forest Baptist — Winston-Salem
• University Hospitals Cleveland — Cleveland
• Providence Cancer Institute Franz Clinic — Portland
• … и ещё 4 центра

Идентификаторы

NCT: NCT06119685 · Indapta-Trial-1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗