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

Indapta Therapeutics

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Multiple Myeloma; Refractory Multiple Myeloma; NHL; Blood Cancer; Relapsed Multiple Myeloma; Relapsed Non-Hodgkin Lymphoma; Refractory Non-Hodgkin Lymphoma

Treatments: Drug: IDP-023; Drug: Interleukin-2; Drug: Cyclophosphamide; Drug: Rituximab; Drug: Daratumumab; Drug: Fludarabine; Drug: Mesna

Study type: Interventional

Funder types: Industry

Identifiers

NCT06119685

Indapta-Trial-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 128 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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128 participants in 5 patient groups

Phase 1: Single Agent IDP-023 - Single Dose

Experimental group

Description:

NHL or MM patient treated with a single dose of IDP-023 monotherapy

Treatment:

Drug: Mesna

Drug: Fludarabine

Drug: Cyclophosphamide

Drug: IDP-023

Phase 1: Single Agent IDP-023 - Multiple Doses

Experimental group

Description:

NHL and MM patients treated with multiple doses of IDP-023 monotherapy

Treatment:

Drug: Mesna

Drug: Fludarabine

Drug: Cyclophosphamide

Drug: IDP-023

Phase 1: Single Agent IDP-023 - Multiple Doses with IL-2

Experimental group

Description:

NHL and MM patients treated with multiple doses of IDP-023 monotherapy

Treatment:

Drug: Mesna

Drug: Fludarabine

Drug: Cyclophosphamide

Drug: Interleukin-2

Drug: IDP-023

Phase 2: Combination IDP-023 plus rituximab

Experimental group

Description:

NHL patients treated with multiple doses of IDP-023 in combination with rituximab

Treatment:

Drug: Mesna

Drug: Fludarabine

Drug: Cyclophosphamide

Drug: Rituximab

Drug: Interleukin-2

Drug: IDP-023

Phase 2: Combination IDP-023 plus daratumumab

Experimental group

Description:

MM patients treated with multiple doses of IDP-023 in combination with daratumumab

Treatment:

Drug: Mesna

Drug: Fludarabine

Drug: Daratumumab

Drug: Cyclophosphamide

Drug: Interleukin-2

Drug: IDP-023