Overview

Phase 1, Dose Escalation and Dose-Expansion Study of ISB 2001 in Relapsed/Refractory Multiple Myeloma

Status:
Not yet recruiting
Trial end date:
2027-07-01
Target enrollment:
0
Participant gender:
All
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).
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Ichnos Sciences SA
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:

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.