RecruitingPhase 1NCT05862012

Study of ISB 2001 in Relapsed/Refractory Multiple Myeloma (TRIgnite-1)

A Phase 1, First-in-Human, Multicenter, Open-Label, Dose Escalation and Dose-Expansion Study of Single-Agent ISB 2001 in Subjects With Relapsed/Refractory Multiple Myeloma

Sponsor

Ichnos Sciences SA

Enrollment

200 participants

Start Date

Nov 1, 2023

Study Type

INTERVENTIONAL

Conditions

Relapsed/Refractory Multiple Myeloma

Summary

This study is a first-in-human, Phase 1, open-label study that will evaluate safety and anti-myeloma activity of ISB 2001 in participants with relapsed/refractory multiple myeloma (R/R MM).

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study (TRIgnite-1) tests ISB 2001, a new type of immunotherapy drug, in people with multiple myeloma (a blood cancer of plasma cells) that has come back or stopped responding to prior treatments. **You may be eligible if...** - You have been diagnosed with multiple myeloma that has relapsed (come back) or is refractory (no longer responding to treatment) - Your disease is still measurable through standard blood, urine, or imaging tests - You are in reasonably good physical condition (ECOG 0–2) - Your blood counts, liver, kidney, and heart function are within acceptable ranges **You may NOT be eligible if...** - Your myeloma has spread to and is actively affecting the central nervous system (brain/spinal cord) - You have an active, serious uncontrolled infection - You have an autoimmune disease requiring immune-suppressing drugs - You are pregnant or breastfeeding 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

DRUGISB 2001

Participants receive escalating doses of ISB 2001

DRUGISB 2001

Participants receive injection of ISB 2001 as determined in Part 1.

Locations(32)

Standford Cancer Institute

Palo Alto, California, United States

Sylvester Cancer Center

Miami, Florida, United States

Winship Cancer Institute

Atlanta, Georgia, United States

University of Chicago Medical Center

Chicago, Illinois, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Montefiore Medical Center

The Bronx, New York, United States

University of North Carolina

Chapel Hill, North Carolina, United States

Tennessee Oncology

Nashville, Tennessee, United States

Virginia Commonwealth University (VCU)

Richmond, Virginia, United States

Froedtert Hospital & the Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Concord Hospital

Concord, New South Wales, Australia

Pindara Private Hospital

Benowa, Queensland, Australia

St. Vincent's Hospital Melbourne

Fitzroy, Victoria, Australia

Peter MacCallum Cancer Center

Melbourne, Victoria, Australia

Linear Clinical Research

Nedlands, Western Australia, Australia

CHRU Lille

Lille, Hauts-de-France, France

CHU Poiters - Hospital la Miletrie

Poitiers, New Aquitaine, France

CHU de Nantes - Hotel Dieu

Nantes, Pays de la Loire Region, France

Groupe Hospitalier Pitie-Salpetriere

Paris, Île-de-France Region, France

Apollo Hospital International Limited

Gandhinagar, Gujarat, India

Health Care Global Enterprises Ltd.

Bangalore, Karnataka, India

Deenanath Mangeshkar Hospital and Research Centre

Pune, Maharashta, India

Apollo Cancer Centers

Hyderabad, Telangana, India

HCG Hospital

Bangalore, India

ASST Spedali Civili di Brescia

Brescia, Lombardy, Italy

Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico

Milan, Lombardy, Italy

Oslo University Hospital

Oslo, Oslo, Norway

Instituto de Investigacion Biomedica de Salamanca (IBSAL)

Salamanca, Castile de Leon, Spain

Institut Catala de Oncologia (ICO)

Badalona, Catalonia, Spain

Hospital Clinic de Barcelona

Barcelona, Catalonia, Spain

Centro Integral Oncologici Clara Campal

Madrid, Madrid, Spain

Clinica Universidad de Nevarra

Pamplona, Navarre, Spain

View Full Details on ClinicalTrials.gov

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NCT05862012

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