IDP-023 as a Single Agent and in Combination With Antibody Therapies in Patients With Advanced Hematologic Cancers
Purpose
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.
Conditions
- NHL
- Multiple Myeloma
- Blood Cancer
- Refractory Non-Hodgkin Lymphoma
- Relapsed Non-Hodgkin Lymphoma
- Refractory Multiple Myeloma
- Relapsed Multiple Myeloma
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- Phase 1/Phase 2
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- 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.
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Phase 1: Single Agent IDP-023 - Single Dose |
NHL or MM patient treated with a single dose of IDP-023 monotherapy |
|
|
Experimental Phase 1: Single Agent IDP-023 - Multiple Doses |
NHL and MM patients treated with multiple doses of IDP-023 monotherapy |
|
|
Experimental Phase 1: Single Agent IDP-023 - Multiple Doses with IL-2 |
NHL and MM patients treated with multiple doses of IDP-023 monotherapy |
|
|
Experimental Phase 2: Combination IDP-023 plus rituximab |
NHL patients treated with multiple doses of IDP-023 in combination with rituximab |
|
|
Experimental Phase 2: Combination IDP-023 plus daratumumab |
MM patients treated with multiple doses of IDP-023 in combination with daratumumab |
|
|
Experimental Phase 2: Combination IDP-023 plus isatuximab |
MM patients treated with multiple doses of IDP-023 in combination with isatuximab |
|
Recruiting Locations
Los Angeles, California 90670
Atlanta, Georgia 30322
Minneapolis, Minnesota 55455
Winston-Salem, North Carolina 27157
Cleveland, Ohio 44106
UH Seidman Cancer Center Cancer Information Service Line
844-885-9659
Providence, Rhode Island 02903
Nashville, Tennessee 37203
Houston, Texas 77030
Fairfax, Virginia 22031
More Details
- Status
- Recruiting
- Sponsor
- Indapta Therapeutics, INC.
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.