RecruitingPhase 1Phase 2NCT06119685

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

Phase 1/2 Study of IDP-023 as a Single Agent and in Combination With Antibody Therapies in Patients With Advanced Hematologic Cancers


Sponsor

Indapta Therapeutics, INC.

Enrollment

128 participants

Start Date

Oct 25, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new treatment called IDP-023, given alone or combined with other antibody drugs, for people with advanced blood cancers including multiple myeloma (a cancer of plasma cells) and non-Hodgkin's lymphoma that have not responded to prior treatments. **You may be eligible if...** - You have multiple myeloma that has relapsed or stopped responding to at least 3 prior treatment regimens - Or you have non-Hodgkin's lymphoma that has relapsed or stopped responding to at least 2 prior chemotherapy regimens - You are in good overall health (ECOG 0 or 1) with a life expectancy of more than 12 weeks **You may NOT be eligible if...** - You have significant heart disease or a history of major cardiac problems - You have HIV, active hepatitis B, or hepatitis C - You have an active COVID-19 infection - You have untreated cancer that has spread to the brain or spinal fluid Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGIDP-023

NK cell therapy

DRUGRituximab

Anti-CD20 antibody therapy

DRUGDaratumumab

Anti-CD38 antibody therapy

DRUGInterleukin-2

Immune cytokine

DRUGCyclophosphamide

Lymphodepleting chemotherapy

DRUGFludarabine

Lymphodepleting chemotherapy

DRUGMesna

Chemoprotectant

DRUGIsatuximab

Anti-CD38 antibody therapy


Locations(12)

Valkyrie Clinical Trials

Los Angeles, California, United States

Florida Cancer Specialists and Research Institute - Lake Mary Cancer Center

Lake Mary, Florida, United States

Emory University Hospital

Atlanta, Georgia, United States

University of Minnesota

Minneapolis, Minnesota, United States

NYP/Weill Cornell Medical Center

New York, New York, United States

Atrium Health Wake Forest Baptist

Winston-Salem, North Carolina, United States

University Hospitals Cleveland

Cleveland, Ohio, United States

Providence Cancer Institute Franz Clinic

Portland, Oregon, United States

Rhode Island Hospital

Providence, Rhode Island, United States

SCRI Oncology Partners

Nashville, Tennessee, United States

University of Texas MD Anderson Cancer Center

Houston, Texas, United States

NEXT Oncology Virginia

Fairfax, Virginia, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT06119685


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