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Clinical Trials in India / NCT05862012
Recruiting Phase 1

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

NCT05862012 · tracked via the Priya Life Science India tracker
Sponsor
Ichnos Sciences SA
Phase
Phase 1
Started
2023-11-01
Last updated
2026-04-01

Condition(s) studied

Relapsed/Refractory Multiple Myeloma

Investigational drug(s) / intervention(s)

ISB 2001ISB 2001

ISB 2001: Participants receive escalating doses of ISB 2001

ISB 2001: Participants receive injection of ISB 2001 as determined in Part 1.

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

Sex
ALL
Min age
18 Years
Max age
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.

Primary outcome measure(s)

Trial sites (32)

FacilityCityRegionStatus
Standford Cancer Institute Palo Alto California Recruiting
Sylvester Cancer Center Miami Florida Active Not Recruiting
Winship Cancer Institute Atlanta Georgia Recruiting
University of Chicago Medical Center Chicago Illinois Recruiting
Beth Israel Deaconess Medical Center Boston Massachusetts Recruiting
Montefiore Medical Center The Bronx New York Recruiting
University of North Carolina Chapel Hill North Carolina Recruiting
Tennessee Oncology Nashville Tennessee Active Not Recruiting
Virginia Commonwealth University (VCU) Richmond Virginia Active Not Recruiting
Froedtert Hospital & the Medical College of Wisconsin Milwaukee Wisconsin Recruiting
Concord Hospital Concord New South Wales Recruiting
Pindara Private Hospital Benowa Queensland Recruiting
St. Vincent's Hospital Melbourne Fitzroy Victoria Recruiting
Peter MacCallum Cancer Center Melbourne Victoria Recruiting
Linear Clinical Research Nedlands Western Australia Recruiting
CHRU Lille Lille Hauts-de-France Recruiting
CHU Poiters - Hospital la Miletrie Poitiers New Aquitaine Recruiting
CHU de Nantes - Hotel Dieu Nantes Pays de la Loire Region Recruiting
Groupe Hospitalier Pitie-Salpetriere Paris Île-de-France Region Recruiting
Apollo Hospital International Limited Gandhinagar Gujarat Active Not Recruiting
Health Care Global Enterprises Ltd. Bangalore Karnataka Active Not Recruiting
Deenanath Mangeshkar Hospital and Research Centre Pune Maharashta Active Not Recruiting
Apollo Cancer Centers Hyderabad Telangana Active Not Recruiting
HCG Hospital Bangalore India Active Not Recruiting
ASST Spedali Civili di Brescia Brescia Lombardy Active Not Recruiting
Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico Milan Lombardy Recruiting
Oslo University Hospital Oslo Oslo Recruiting
Instituto de Investigacion Biomedica de Salamanca (IBSAL) Salamanca Castile de Leon Recruiting
Institut Catala de Oncologia (ICO) Badalona Catalonia Recruiting
Hospital Clinic de Barcelona Barcelona Catalonia Recruiting
Centro Integral Oncologici Clara Campal Madrid Madrid Active Not Recruiting
Clinica Universidad de Nevarra Pamplona Navarre Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05862012 on ClinicalTrials.gov ↗ ← All trials in India