Study on IDP-023 Alone and with Antibody Therapies for Advanced Blood Cancers
Sponsor: Indapta Therapeutics, INC.
ClinicalTrials ID:NCT06119685
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
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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:
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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.
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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.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Valkyrie Clinical Trials | 90670 | Los Angeles | California |
| Florida Cancer Specialists and Research Institute - Lake Mary Cancer Center | 32746 | Lake Mary | Florida |
| Emory University Hospital | 30322 | Atlanta | Georgia |
| University of Minnesota | 55455 | Minneapolis | Minnesota |
| NYP/Weill Cornell Medical Center | 10065 | New York | New York |
| Atrium Health Wake Forest Baptist | 27157 | Winston-Salem | North Carolina |
| University Hospitals Cleveland | 44106 | Cleveland | Ohio |
| Providence Cancer Institute Franz Clinic | 97213 | Portland | Oregon |
| Rhode Island Hospital | 02903 | Providence | Rhode Island |
| SCRI Oncology Partners | 37203 | Nashville | Tennessee |
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