Study on IDP-023 Alone and with Antibody Therapies for Advanced Blood Cancers

Sponsor: Indapta Therapeutics, INC.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06119685

Provider View

This clinical trial is testing a new treatment called IDP-023, which uses natural killer cells to target cancer. The study will see if IDP-023 is safe and effective when used alone or with other treatments in patients with advanced blood cancers like multiple myeloma and non-Hodgkin's lymphoma.

Patient Parameters

Program Overview

This study is exploring a new treatment called IDP-023, which is made from natural killer (NK) cells, a type of white blood cell that can attack cancer cells. The trial will test IDP-023 on its own and in combination with other treatments, such as interleukin-2 (IL-2), daratumumab, or rituximab, to see if it is safe and effective for patients with advanced blood cancers like multiple myeloma and non-Hodgkin's lymphoma. The study is divided into two phases: Phase 1 will determine the safest dose, and Phase 2 will evaluate how well the treatment works.

Description

IDP-023 is a new treatment made from natural killer (NK) cells, which are a type of white blood cell that can destroy cancer cells. This study is testing IDP-023 in patients with advanced blood cancers, specifically multiple myeloma (MM) and non-Hodgkin's lymphoma (NHL), to see if it is safe and effective.

The study has two parts:

  • Phase 1 (Escalation Phase): This part will test different doses of IDP-023 to find the safest and most effective dose. It will also explore how IDP-023 works when combined with other treatments like interleukin-2 (IL-2), daratumumab, or rituximab.

  • Phase 2 (Expansion Phase): This part will further test the safety and effectiveness of IDP-023 in patients with advanced multiple myeloma when combined with daratumumab, and in patients with advanced non-Hodgkin's lymphoma when combined with rituximab.

The goal is to find out if IDP-023 can help control these cancers and improve patient outcomes.

Eligibility Criteria

Inclusion Criteria

  • For multiple myeloma (MM) patients: Must have a confirmed diagnosis of MM that requires treatment and has not responded to at least 3 previous treatments.
  • For non-Hodgkin's lymphoma (NHL) patients: Must have NHL that has not responded to at least 2 previous chemotherapy treatments.
  • Must be in good overall health, with a performance status score of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Must have a life expectancy of more than 12 weeks, as determined by the study doctor.

Exclusion Criteria

  • Have significant heart problems or a history of serious heart disease.
  • Have an active infection with HIV, hepatitis B, or hepatitis C.
  • Have an active COVID-19 infection.
  • Have untreated cancer that has spread to the brain or spinal cord.

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