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

Last updated: March 31, 2026
Sponsor: Ichnos Sciences SA
Overall Status: Active - Recruiting

Phase

1

Condition

Lymphoproliferative Disorders

Multiple Myeloma

Red Blood Cell Disorders

Treatment

ISB 2001

Clinical Study ID

NCT05862012
ISB 2001-101
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  1. Participants with pathologically confirmed MM with measurable M-protein: serumand/or 24 hour urine, serum-free light chains or measurable isolated plasmacytoma

  2. Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 2 orless

  3. Must have adequate hematologic, hepatic, renal, and cardiac functions

Exclusion

Exclusion Criteria:

  1. Active malignant central nervous system involvement

  2. Uncontrolled infection requiring systemic antibiotic therapy or other seriousinfection prior to C1D1

  3. History of autoimmune disease requiring systemic immunosuppressive therapy

  4. Any concurrent or uncontrolled medical, comorbid, psychiatric or social conditionthat would limit compliance with study procedures, interfere with the study results,substantially increase the risk of AEs, compromise ability to provide writteninformed consent or, in the opinion of the Investigator, constitute a hazard forparticipating in this study.

  5. Female subjects who are lactating and breastfeeding or have a positive pregnancytest during the screening period or on Day 1 before first dose of ISB 2001.

Study Design

Total Participants: 200
Treatment Group(s): 1
Primary Treatment: ISB 2001
Phase: 1
Study Start date:
November 01, 2023
Estimated Completion Date:
July 31, 2027

Study Description

The study enrolls participants with R/R MM that have been treated with immunomodulatory drugs (IMiDs), proteasome inhibitors, and anti-CD38 therapies either in combination or as a single agent and are refractory to, or intolerant of, established therapies known to provide clinical benefit in MM.

The study is conducted in two parts: Part 1 dose escalation and Part 2 dose expansion.

Dose escalation continued until the maximum planned dose was reached. Dose expansion cohorts were initiated to further confirm safety and optimal biologically active dose. Participants receive ISB 2001 until disease progression, unacceptable toxicity occurs, any criterion for stopping the study treatment, or participant withdrawal from the study.

Connect with a study center

  • Concord Hospital

    Concord, New South Wales 2139
    Australia

    Active - Recruiting

  • Concord Hospital

    Concord 2170852, New South Wales 2155400 2139
    Australia

    Site Not Available

  • Pindara Private Hospital

    Benowa, Queensland 4217
    Australia

    Active - Recruiting

  • Pindara Private Hospital

    Benowa 2176127, Queensland 2152274 4217
    Australia

    Site Not Available

  • St. Vincent's Hospital Melbourne

    Fitzroy, Victoria 3065
    Australia

    Active - Recruiting

  • Peter MacCallum Cancer Center

    Melbourne, Victoria 3000
    Australia

    Active - Recruiting

  • St. Vincent's Hospital Melbourne

    Fitzroy 2166584, Victoria 2145234 3065
    Australia

    Site Not Available

  • Peter MacCallum Cancer Center

    Melbourne 2158177, Victoria 2145234 3000
    Australia

    Site Not Available

  • Linear Clinical Research

    Nedlands, Western Australia 6009
    Australia

    Active - Recruiting

  • Linear Clinical Research

    Nedlands 2064874, Western Australia 2058645 6009
    Australia

    Site Not Available

  • CHRU Lille

    Lille, Hauts-de-France 59800
    France

    Active - Recruiting

  • CHU Poiters - Hospital la Miletrie

    Poitiers, Nouvelle-Aquitaine 86021
    France

    Active - Recruiting

  • CHU de Nantes - Hotel Dieu

    Nantes, Pays de la Loire Region 44093
    France

    Active - Recruiting

  • Groupe Hospitalier Pitie-Salpetriere

    Paris, Île-de-France Region 75013
    France

    Active - Recruiting

  • Apollo Hospital International Limited

    Gandhinagar, Gujarat 382428
    India

    Site Not Available

  • Health Care Global Enterprises Ltd.

    Bangalore, Karnataka 560027
    India

    Site Not Available

  • Deenanath Mangeshkar Hospital and Research Centre

    Pune, Maharashta 411004
    India

    Site Not Available

  • Apollo Cancer Centers

    Hyderabad, Telangana 500033
    India

    Site Not Available

  • HCG Hospital

    Bangalore,
    India

    Site Not Available

  • HCG Hospital

    Bangalore 1277333,
    India

    Site Not Available

  • ASST Spedali Civili di Brescia

    Brescia, Lombardy 25123
    Italy

    Site Not Available

  • Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico

    Milan, Lombardy 20122
    Italy

    Active - Recruiting

  • Oslo University Hospital

    Oslo, Oslo County 0372
    Norway

    Active - Recruiting

  • Instituto de Investigacion Biomedica de Salamanca (IBSAL)

    Salamanca, Castile de Leon 37007
    Spain

    Active - Recruiting

  • Institut Catala de Oncologia (ICO)

    Badalona, Catalonia 08916
    Spain

    Active - Recruiting

  • Hospital Clinic de Barcelona

    Barcelona, Catalonia 08036
    Spain

    Active - Recruiting

  • Centro Integral Oncologici Clara Campal

    Madrid, Madrid 28050
    Spain

    Site Not Available

  • Clinica Universidad de Nevarra

    Pamplona, Navarre 31008
    Spain

    Active - Recruiting

  • Standford Cancer Institute

    Palo Alto, California 94304
    United States

    Active - Recruiting

  • Standford Cancer Institute

    Palo Alto 5380748, California 5332921 94304
    United States

    Site Not Available

  • Sylvester Cancer Center

    Miami, Florida 33136
    United States

    Site Not Available

  • Winship Cancer Institute

    Atlanta, Georgia 30322
    United States

    Active - Recruiting

  • University of Chicago Medical Center

    Chicago, Illinois 60637
    United States

    Active - Recruiting

  • University of Chicago Medical Center

    Chicago 4887398, Illinois 4896861 60637
    United States

    Site Not Available

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts 02215
    United States

    Active - Recruiting

  • Montefiore Medical Center

    Bronx, New York 10467
    United States

    Site Not Available

  • Montefiore Medical Center

    The Bronx, New York 10467
    United States

    Active - Recruiting

  • Montefiore Medical Center

    The Bronx 5110266, New York 5128638 10467
    United States

    Site Not Available

  • University of North Carolina

    Chapel Hill, North Carolina 27599
    United States

    Active - Recruiting

  • University of North Carolina

    Chapel Hill 4460162, North Carolina 4482348 27599
    United States

    Site Not Available

  • Tennessee Oncology

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Virginia Commonwealth University (VCU)

    Richmond, Virginia 23298
    United States

    Site Not Available

  • Froedtert Hospital & the Medical College of Wisconsin

    Milwaukee, Wisconsin 53226
    United States

    Active - Recruiting

  • Froedtert Hospital & the Medical College of Wisconsin

    Milwaukee 5263045, Wisconsin 5279468 53226
    United States

    Site Not Available

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