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RECRUITINGPhase 1NCT05862012

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

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).

Lead sponsor: Ichnos Sciences SA•5 U.S. locations•View source on ClinicalTrials.gov

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Contacts

Ichnos Sciences Clinical Trials Administrator

CONTACT

(315) 583-1249 clinicaltrials@ichnossciences.com

Sponsors

Lead Sponsor

Ichnos Sciences SA

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.

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

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.

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: March 13, 2026Terms

Trial snapshot

StatusRECRUITING

PhasePHASE1

Enrollment200

Start dateNov 2023

Last updatedMar 13, 2026

Condition

Relapsed/Refractory Multiple Myeloma

Locations shown

Standford Cancer Institute

Palo Alto, California

University of Chicago Medical Center

Chicago, Illinois

Montefiore Medical Center

The Bronx, New York

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 13, 2026Data synced to Clareo: May 10, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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