For Healthcare Professionals

Study of ISB 2001 in Relapsed/Refractory Multiple Myeloma

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About the study

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).
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Inclusion Criteria:

  1. Participants with pathologically confirmed MM with measurable M-protein: serum and/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 or less
  3. Must have adequate hematologic, hepatic, renal, and cardiac functions

EXCLUSION CRITERIA

Exclusion Criteria:

  1. Active malignant central nervous system involvement
  2. Uncontrolled infection requiring systemic antibiotic therapy or other serious infection prior to C1D1
  3. History of autoimmune disease requiring systemic immunosuppressive therapy
  4. Any concurrent or uncontrolled medical, comorbid, psychiatric or social condition that would limit compliance with study procedures, interfere with the study results, substantially increase the risk of AEs, compromise ability to provide written informed consent or, in the opinion of the Investigator, constitute a hazard for participating in this study.
  5. Female subjects who are lactating and breastfeeding or have a positive pregnancy test during the screening period or on Day 1 before first dose of ISB 2001.
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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.
Phone iconCall (315) 583-1249Email iconEmail Study Center

Study Details


Contition

Relapsed/Refractory Multiple Myeloma

Age

18+

Phase

PHASE1

Participants Needed

80

Est. Completion Date

Jul 31, 2027

Treatment Type

INTERVENTIONAL


Sponsor

Ichnos Sciences SA

ClinicalTrials.gov NCT Identifier

NCT05862012

Study Number

ISB 2001-101

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