Study of ISB 2001 in Relapsed/Refractory Multiple Myeloma

Description

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).

Conditions

Relapsed/Refractory Multiple Myeloma

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Study Overview

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Study Details

Study overview

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).

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

Study of ISB 2001 in Relapsed/Refractory Multiple Myeloma

Condition
Relapsed/Refractory Multiple Myeloma
Intervention / Treatment

-

Contacts and Locations

Bronx

Montefiore Medical Center, Bronx, New York, United States, 10467

Chapel Hill

University of North Carolina, Chapel Hill, North Carolina, United States, 27599

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Ichnos Sciences SA,

Study Record Dates

2027-07