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

Sponsor

Indapta Therapeutics, INC. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT06119685

Collaborator

(none)

128

Enrollment

Locations

Arms

Anticipated Duration (Months)

42.7

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

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 daratumumab or rituximab to evaluate the safety, tolerability and preliminary antitumor activity in patients with advanced hematologic cancers.

Condition or Disease	Intervention/Treatment	Phase
NHL Multiple Myeloma Blood Cancer Refractory Non-Hodgkin Lymphoma Relapsed Non-Hodgkin Lymphoma Refractory Multiple Myeloma Relapsed Multiple Myeloma	Drug: IDP-023 Drug: Rituximab Drug: Daratumumab Drug: Interleukin-2 Drug: Cyclophosphamide Drug: Fludarabine Drug: Mesna	Phase 1/Phase 2

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 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 daratumumab and advanced NHL in combination with rituximab.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

128 participants

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 daratumumab or rituximab.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 daratumumab or rituximab.

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Oct 31, 2023

Anticipated Primary Completion Date :

Dec 30, 2025

Anticipated Study Completion Date :

Dec 31, 2029

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Phase 1: Single Agent IDP-023 - Single Dose NHL or MM patient treated with a single dose of IDP-023 monotherapy	Drug: IDP-023 NK cell therapy Drug: Cyclophosphamide Lymphodepleting chemotherapy Drug: Fludarabine Lymphodepleting chemotherapy Drug: Mesna Chemoprotectant
Experimental: Phase 1: Single Agent IDP-023 - Multiple Doses NHL and MM patients treated with multiple doses of IDP-023 monotherapy	Drug: IDP-023 NK cell therapy Drug: Cyclophosphamide Lymphodepleting chemotherapy Drug: Fludarabine Lymphodepleting chemotherapy Drug: Mesna Chemoprotectant
Experimental: Phase 1: Single Agent IDP-023 - Multiple Doses with IL-2 NHL and MM patients treated with multiple doses of IDP-023 monotherapy	Drug: IDP-023 NK cell therapy Drug: Interleukin-2 Immune cytokine Other Names: Proleukin Drug: Cyclophosphamide Lymphodepleting chemotherapy Drug: Fludarabine Lymphodepleting chemotherapy Drug: Mesna Chemoprotectant
Experimental: Phase 2: Combination IDP-023 plus rituximab NHL patients treated with multiple doses of IDP-023 in combination with rituximab	Drug: IDP-023 NK cell therapy Drug: Rituximab Anti-CD20 antibody therapy Other Names: Rituxan Drug: Interleukin-2 Immune cytokine Other Names: Proleukin Drug: Cyclophosphamide Lymphodepleting chemotherapy Drug: Fludarabine Lymphodepleting chemotherapy Drug: Mesna Chemoprotectant
Experimental: Phase 2: Combination IDP-023 plus daratumumab MM patients treated with multiple doses of IDP-023 in combination with daratumumab	Drug: IDP-023 NK cell therapy Drug: Daratumumab Anti-CD38 antibody therapy Other Names: Darzalex Drug: Interleukin-2 Immune cytokine Other Names: Proleukin Drug: Cyclophosphamide Lymphodepleting chemotherapy Drug: Fludarabine Lymphodepleting chemotherapy Drug: Mesna Chemoprotectant

Outcome Measures

Primary Outcome Measures

Incidence of adverse events (AEs) and serious adverse events (SAEs) - (Phase 1) [1 year]
Escalation Period
Incidence of dose-limiting toxicities (DLTs) of IDP-023 Monotherapy - (Phase 1) [up to 21 days]
Escalation Period
Nature of dose-limiting toxicities (DLTs) of IDP-023 Monotherapy - (Phase 1) [up to 21 days]
Escalation Period
Incidence of dose-limiting toxicities (DLTs) of IDP-023 in combination with Daratumumab or Rituximab - (Phase 1) [up to 35 days]
Escalation Period
Nature of dose-limiting toxicities (DLTs) of IDP-023 in combination with Daratumumab or Rituximab - (Phase 1) [up to 35 days]
Escalation Period
Maximum tolerable dose (MTD) or a tolerated dose below MTD - (Phase 1) [1 year]
Escalation Period
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) [2 years]
Expansion period
For NHL: Anti-tumor activity by objective response rate (ORR) - (Phase 2) [2 years]
Expansion period

Secondary Outcome Measures

PK (Cmax) of IDP-023 - (Phase 1/2) [2 years]
Escalation and expansion periods
PK (AUC) of IDP-023 - (Phase 1/2) [2 years]
Escalation and expansion periods
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) [1 year]
Escalation period
For NHL: Anti-tumor activity by objective response rate (ORR) - (Phase 1) [1 year]
Escalation period
Incidence of adverse events (AEs) and serious adverse events (SAEs) - (Phase 2) [2 years]
Expansion period

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Minnesota	Minneapolis	Minnesota	United States	55455
2	University of Texas MD Anderson Cancer Center	Houston	Texas	United States	77030
3	NEXT Oncology Virginia	Fairfax	Virginia	United States	22031