Study of ISB 2001 in Relapsed/Refractory Multiple Myeloma

Last updated: December 17, 2024
Sponsor: Ichnos Sciences SA
Overall Status: Active - Recruiting

Phase

1

Condition

Multiple Myeloma

Cancer/tumors

Leukemia

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: 80
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 will enroll 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 will be conducted in two parts:

  • Part 1: Dose escalation

  • Part 2: Dose expansion

Dose escalation will continue until either the maximum tolerated dose (MTD) is defined, the maximum planned dose is reached, or a recommended phase 2 dose (RP2D) is selected. Dose expansion cohorts will be initiated to further confirm safety and optimal biologically active dose. Participants will 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

  • Pindara Private Hospital

    Benowa, Queensland 4217
    Australia

    Active - Recruiting

  • St. Vincent's Hospital Melbourne

    Fitzroy, Victoria 3065
    Australia

    Active - Recruiting

  • Peter MacCallum Cancer Center

    Melbourne, Victoria 3000
    Australia

    Active - Recruiting

  • Linear Clinical Research

    Nedlands, Western Australia 6009
    Australia

    Active - Recruiting

  • HCG Hospital

    Bangalore,
    India

    Active - Recruiting

  • Standford Cancer Institute

    Palo Alto, California 94304
    United States

    Active - Recruiting

  • Montefiore Medical Center

    Bronx, New York 10467
    United States

    Active - Recruiting

  • University of North Carolina

    Chapel Hill, North Carolina 27599
    United States

    Active - Recruiting

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