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

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.

• IDP-023 (Drug): NK cell therapy
• Rituximab (Drug), also known as Rituxan: Anti-CD20 antibody therapy
• Daratumumab (Drug), also known as Darzalex: Anti-CD38 antibody therapy
• Interleukin-2 (Drug), also known as Proleukin: Immune cytokine
• Cyclophosphamide (Drug): Lymphodepleting chemotherapy
• Fludarabine (Drug): Lymphodepleting chemotherapy
• Mesna (Drug): Chemoprotectant
• Isatuximab (Drug), also known as Sarclisa: Anti-CD38 antibody therapy

Primary outcomes

• 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 Isatuximab, Daratumumab or Rituximab - (Phase 1) [up to 35 days]: Escalation Period
• Nature of dose-limiting toxicities (DLTs) of IDP-023 in combination with Isatuximab, 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 outcomes

• 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

Sex: All, ages: 18 Years to any

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.

• Indapta Therapeutics, Inc., Study director, Indapta Therapeutics, INC.