IDP-023 as a Single Agent and in Combination With Antibody Therapies in Patients With Advanced Hematologic Cancers
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: IDP-023, Rituximab, Daratumumab, Interleukin-2.
- Who it may be relevant to
- Registry conditions: NHL, Multiple Myeloma, Blood Cancer, Refractory Non-Hodgkin Lymphoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Phase 1/2 Study of IDP-023 as a Single Agent and in Combination With Antibody Therapies in Patients With Advanced Hematologic Cancers
Overview
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.
Interventions
- 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
Primary outcome measures
- Incidence of adverse events (AEs) and serious adverse events (SAEs) - (Phase 1) [Time frame: 1 year]
- Incidence of dose-limiting toxicities (DLTs) of IDP-023 Monotherapy - (Phase 1) [Time frame: up to 21 days]
- Nature of dose-limiting toxicities (DLTs) of IDP-023 Monotherapy - (Phase 1) [Time frame: up to 21 days]
- Incidence of dose-limiting toxicities (DLTs) of IDP-023 in combination with Isatuximab, Daratumumab or Rituximab - (Phase 1) [Time frame: up to 35 days]
- Nature of dose-limiting toxicities (DLTs) of IDP-023 in combination with Isatuximab, Daratumumab or Rituximab - (Phase 1) [Time frame: up to 35 days]
- Maximum tolerable dose (MTD) or a tolerated dose below MTD - (Phase 1) [Time frame: 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) [Time frame: 2 years]
- For NHL: Anti-tumor activity by objective response rate (ORR) - (Phase 2) [Time frame: 2 years]
Secondary outcome measures (5)
- PK (Cmax) of IDP-023 - (Phase 1/2) [Time frame: 2 years]
- PK (AUC) of IDP-023 - (Phase 1/2) [Time frame: 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) [Time frame: 1 year]
- For NHL: Anti-tumor activity by objective response rate (ORR) - (Phase 1) [Time frame: 1 year]
- Incidence of adverse events (AEs) and serious adverse events (SAEs) - (Phase 2) [Time frame: 2 years]
Eligibility criteria
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.
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 12 centers
- 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
- … and 4 more centers
Identifiers
NCT: NCT06119685 · Indapta-Trial-1