IDP-023 as a Single Agent and in Combination With Antibody Therapies in Patients With Advanced Hematologic Cancers
Sponsor: Indapta Therapeutics, INC.
ClinicalTrials ID:NCT06119685
This Phase 1/2 study evaluates IDP-023, an NK cell therapy, alone and with IL-2, daratumumab, or rituximab in advanced MM and NHL. Phase 1 focuses on safety and dose determination, while Phase 2 assesses efficacy. Eligible patients have relapsed/refractory MM or NHL, ECOG 0-1, and >12-week life expectancy. Interventions include rituximab, daratumumab, IL-2, cyclophosphamide, fludarabine, and mesna.
Patient Parameters
| Parameter | Options |
|---|
Program 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.
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.
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.
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 infection.
- Active SARS-CoV-2 infection.
- Has untreated central nervous system, epidural tumor metastasis, or brain metastasis.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Valkyrie Clinical Trials | 90670 | Los Angeles | California |
| Florida Cancer Specialists and Research Institute - Lake Mary Cancer Center | 32746 | Lake Mary | Florida |
| Emory University Hospital | 30322 | Atlanta | Georgia |
| University of Minnesota | 55455 | Minneapolis | Minnesota |
| NYP/Weill Cornell Medical Center | 10065 | New York | New York |
| Atrium Health Wake Forest Baptist | 27157 | Winston-Salem | North Carolina |
| University Hospitals Cleveland | 44106 | Cleveland | Ohio |
| Providence Cancer Institute Franz Clinic | 97213 | Portland | Oregon |
| Rhode Island Hospital | 02903 | Providence | Rhode Island |
| SCRI Oncology Partners | 37203 | Nashville | Tennessee |
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