Study of ISB 2001 in Relapsed/Refractory Multiple Myeloma (TRIgnite-1)
NCT ID: NCT05862012
Last Updated: 2025-09-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
80 participants
INTERVENTIONAL
2023-11-01
2027-07-31
Brief Summary
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Detailed Description
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The study will be conducted in two parts:
* Part 1: Dose escalation
* Part 2: Dose expansion
Dose escalation will continue until either the maximum tolerated dose (MTD) is defined, the maximum planned dose is reached, or a recommended phase 2 dose (RP2D) is selected. Dose expansion cohorts will be initiated to further confirm safety and optimal biologically active dose. Participants will receive ISB 2001 until disease progression, unacceptable toxicity occurs, any criterion for stopping the study treatment, or participant withdrawal from the study.
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Part 1: Dose Escalation
Participants with R/R MM will be administered ISB 2001 weekly on Days 1, 8, 15, and 22 of each 28-day cycle, with an additional step-up dose in Cycle 1 on Day 4. Treatment cycle duration is 28 days. Participants will receive ISB 2001 until disease progression, unacceptable toxicity occurs, any criterion for stopping the study treatment or participant withdrawal from the study
ISB 2001
Participants will receive escalating doses of ISB 2001
Part 2: Dose Expansion
Dose expansion cohorts will be initiated to further confirm safety and optimal biologically active dose. Participants will receive ISB 2001 until disease progression, unacceptable toxicity occurs, any criterion for stopping the study treatment or participant withdrawal from the study.
ISB 2001
Participants will receive injection of ISB 2001 as determined in Part 1.
Interventions
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ISB 2001
Participants will receive escalating doses of ISB 2001
ISB 2001
Participants will receive injection of ISB 2001 as determined in Part 1.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Ichnos Sciences SA
INDUSTRY
Responsible Party
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Locations
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Standford Cancer Institute
Palo Alto, California, United States
University of Chicago Medical Center
Chicago, Illinois, United States
Montefiore Medical Center
The Bronx, New York, United States
University of North Carolina
Chapel Hill, North Carolina, United States
Froedtert Hospital & the Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Concord Hospital
Concord, New South Wales, Australia
Pindara Private Hospital
Benowa, Queensland, Australia
St. Vincent's Hospital Melbourne
Fitzroy, Victoria, Australia
Peter MacCallum Cancer Center
Melbourne, Victoria, Australia
Linear Clinical Research
Nedlands, Western Australia, Australia
HCG Hospital
Bangalore, , India
Countries
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Central Contacts
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Facility Contacts
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References
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Carretero-Iglesia L, Hall OJ, Berret J, Pais D, Estoppey C, Chimen M, Monney T, Loyau J, Dreyfus C, Macoin J, Perez C, Menon V, Gruber I, Laurendon A, Caro LN, Gudi GS, Matsuura T, van der Graaf PH, Blein S, Mbow ML, Croasdale-Wood R, Srivastava A, Dyson MR, Matthes T, Kaya Z, Edwards CM, Edwards JR, Maiga S, Pellat-Deceunynck C, Touzeau C, Moreau P, Konto C, Drake A, Zhukovsky EA, Perro M, Pihlgren M. ISB 2001 trispecific T cell engager shows strong tumor cytotoxicity and overcomes immune escape mechanisms of multiple myeloma cells. Nat Cancer. 2024 Oct;5(10):1494-1514. doi: 10.1038/s43018-024-00821-1. Epub 2024 Sep 11.
Other Identifiers
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ISB 2001-101
Identifier Type: -
Identifier Source: org_study_id
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