Clinical trial NCT06119685: IDP-023 as a Single Agent and in Combination With Antibody Therapies in Patients With Advanced Hematologic Cancers
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: NHL
Multiple Myeloma
Blood Cancer
Refractory Non-Hodgkin Lymphoma
Relapsed Non-Hodgkin Lymphoma
Refractory Multiple Myeloma
Relapsed Multiple Myeloma
Keywords: Advanced Hematologic Cancers
Lead sponsor: Indapta Therapeutics, INC.
Sponsor class: INDUSTRY
First posted: 2023-11-07
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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

Brief summary: 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.

Eligibility criteria: Key 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.

Primary outcomes:
measure: Incidence of adverse events (AEs) and serious adverse events (SAEs) - (Phase 1)
timeFrame: 1 year
measure: Incidence of dose-limiting toxicities (DLTs) of IDP-023 Monotherapy - (Phase 1)
timeFrame: up to 21 days
measure: Nature of dose-limiting toxicities (DLTs) of IDP-023 Monotherapy - (Phase 1)
timeFrame: up to 21 days
measure: Incidence of dose-limiting toxicities (DLTs) of IDP-023 in combination with Isatuximab, Daratumumab or Rituximab - (Phase 1)
timeFrame: up to 35 days
measure: Nature of dose-limiting toxicities (DLTs) of IDP-023 in combination with Isatuximab, Daratumumab or Rituximab - (Phase 1)
timeFrame: up to 35 days
measure: Maximum tolerable dose (MTD) or a tolerated dose below MTD - (Phase 1)
timeFrame: 1 year
measure: 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)
timeFrame: 2 years
measure: For NHL: Anti-tumor activity by objective response rate (ORR) - (Phase 2)
timeFrame: 2 years
Secondary outcomes:
measure: PK (Cmax) of IDP-023 - (Phase 1/2)
timeFrame: 2 years
measure: PK (AUC) of IDP-023 - (Phase 1/2)
timeFrame: 2 years
measure: 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)
timeFrame: 1 year
measure: For NHL: Anti-tumor activity by objective response rate (ORR) - (Phase 1)
timeFrame: 1 year
measure: Incidence of adverse events (AEs) and serious adverse events (SAEs) - (Phase 2)
timeFrame: 2 years
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Valkyrie Clinical Trials
state: California
city: Lake Mary
country: United States
facility: Florida Cancer Specialists and Research Institute - Lake Mary Cancer Center
state: Florida
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: New York
country: United States
facility: NYP/Weill Cornell Medical Center
state: New York
city: Winston-Salem
country: United States
facility: Atrium Health Wake Forest Baptist
state: North Carolina
city: Cleveland
country: United States
facility: University Hospitals Cleveland
state: Ohio
city: Portland
country: United States
facility: Providence Cancer Institute Franz Clinic
state: Oregon
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Nashville
country: United States
facility: SCRI Oncology Partners
state: Tennessee
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
city: Fairfax
country: United States
facility: NEXT Oncology Virginia
state: Virginia
Study officials:
affiliation: Indapta Therapeutics, INC.
name: Indapta Therapeutics, Inc.
role: STUDY_DIRECTOR
References: