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

Sponsor: Indapta Therapeutics, INC.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06119685

Patient View

This Phase 1/2 study evaluates IDP-023, an NK cell therapy, alone and with IL-2, daratumumab, or rituximab in advanced MM and NHL. Phase 1 focuses on safety and dose determination, while Phase 2 assesses efficacy. Eligible patients have relapsed/refractory MM or NHL, ECOG 0-1, and >12-week life expectancy. Interventions include rituximab, daratumumab, IL-2, cyclophosphamide, fludarabine, and mesna.

Patient Parameters

Program Overview

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.

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

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.

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