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

NCT05862012 | Recruiting Phase 1 FDA Drug

• 1 other identifier: ISB 2001-101
• Study Type: interventional
• Target: 200
• Locations: 7 countries
• Sites: 32

Brief 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).

Conditions

Relapsed/Refractory Multiple Myeloma

Keywords

ISB 2001; Relapsed/refractory multiple myeloma; Open-label; Dose escalation; Dose expansion

Outcome Measures

Primary Outcomes (2)

• Frequency and Severity Of Treatment-Emergent Adverse Events (TEAEs)

  Up to 18 months

• Number of Dose-Limiting Toxicities (DLT) During the First 28 Days After the First Administration of ISB 2001 (Cycle 1) in Each Cohort (Part 1)

  Up to 28 days

Secondary Outcomes (13)

• Maximum Concentration (Cmax) of ISB 2001 in Serum

  Up to 28 days

• Time to Reach Maximum Concentration (Tmax) of ISB 2001 in Serum

  Up to 28 days

• Area Under the Concentration Time Curve in Dosing Intervals (AUC0-tau) of ISB 2001 in Serum

  Up to 28 days

• Area Under the Concentration Time Curve From Zero to Time t (AUC0-t) of ISB 2001 in Serum

  Up to 28 days

• Percent Incidence of Anti-Drug Antibody (ADA), Neutralizing Antibody (nAb) and Titer of ADA From Baseline Until End-of-Treatment (EOT)

  Baseline to 18 months

Study Arms (2)

Part 1: Dose Escalation

EXPERIMENTAL

Participants with R/R MM is 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

Drug: ISB 2001

Part 2: Dose Expansion

EXPERIMENTAL

Dose expansion cohorts are 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.

Drug: ISB 2001

Interventions

ISB 2001 DRUG

Participants receive escalating doses of ISB 2001

Part 1: Dose Escalation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants with pathologically confirmed MM with measurable M-protein: serum and/or 24 hour urine, serum-free light chains or measurable isolated plasmacytoma
• Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less
• Must have adequate hematologic, hepatic, renal, and cardiac functions

You may not qualify if:

• Active malignant central nervous system involvement
• Uncontrolled infection requiring systemic antibiotic therapy or other serious infection prior to C1D1
• History of autoimmune disease requiring systemic immunosuppressive therapy
• 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.
• 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.

Sponsors & Collaborators

• Ichnos Sciences SA: lead

Study Sites (32)

Standford Cancer Institute

Palo Alto, California, 94304, United States

RECRUITING

Sylvester Cancer Center

Miami, Florida, 33136, United States

ACTIVE NOT RECRUITING

Winship Cancer Institute

Atlanta, Georgia, 30322, United States

RECRUITING

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

RECRUITING

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

RECRUITING

Montefiore Medical Center

The Bronx, New York, 10467, United States

RECRUITING

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

RECRUITING

Tennessee Oncology

Nashville, Tennessee, 37203, United States

ACTIVE NOT RECRUITING

Virginia Commonwealth University (VCU)

Richmond, Virginia, 23298, United States

ACTIVE NOT RECRUITING

Froedtert Hospital & the Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

RECRUITING

Concord Hospital

Concord, New South Wales, 2139, Australia

RECRUITING

Pindara Private Hospital

Benowa, Queensland, 4217, Australia

RECRUITING

St. Vincent's Hospital Melbourne

Fitzroy, Victoria, 3065, Australia

RECRUITING

Peter MacCallum Cancer Center

Melbourne, Victoria, 3000, Australia

RECRUITING

Linear Clinical Research

Nedlands, Western Australia, 6009, Australia

RECRUITING

CHRU Lille

Lille, Hauts-de-France, 59800, France

RECRUITING

CHU Poiters - Hospital la Miletrie

Poitiers, Nouvelle-Aquitaine, 86021, France

RECRUITING

CHU de Nantes - Hotel Dieu

Nantes, Pays de la Loire Region, 44093, France

RECRUITING

Groupe Hospitalier Pitie-Salpetriere

Paris, Île-de-France Region, 75013, France

RECRUITING

Apollo Hospital International Limited

Gandhinagar, Gujarat, 382428, India

ACTIVE NOT RECRUITING

Health Care Global Enterprises Ltd.

Bangalore, Karnataka, 560027, India

ACTIVE NOT RECRUITING

Deenanath Mangeshkar Hospital and Research Centre

Pune, Maharashta, 411004, India

ACTIVE NOT RECRUITING

Apollo Cancer Centers

Hyderabad, Telangana, 500033, India

ACTIVE NOT RECRUITING

HCG Hospital

Bangalore, India

ACTIVE NOT RECRUITING

ASST Spedali Civili di Brescia

Brescia, Lombardy, 25123, Italy

ACTIVE NOT RECRUITING

Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico

Milan, Lombardy, 20122, Italy

RECRUITING

Oslo University Hospital

Oslo, Oslo County, 0372, Norway

RECRUITING

Instituto de Investigacion Biomedica de Salamanca (IBSAL)

Salamanca, Castile de Leon, 37007, Spain

RECRUITING

Institut Catala de Oncologia (ICO)

Badalona, Catalonia, 08916, Spain

RECRUITING

Hospital Clinic de Barcelona

Barcelona, Catalonia, 08036, Spain

RECRUITING

Centro Integral Oncologici Clara Campal

Madrid, Madrid, 28050, Spain

ACTIVE NOT RECRUITING

Clinica Universidad de Nevarra

Pamplona, Navarre, 31008, Spain

RECRUITING

Related Publications (1)

• 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.

  PMID: 39261676 DERIVED

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Ichnos Sciences Clinical Trials Administrator

CONTACT

(315) 583-1249; clinicaltrials@ichnossciences.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2023
• First Posted: May 17, 2023
• Study Start: November 1, 2023
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

IN (5); AU (5); US (10); NO (1); ES (5); IT (2); FR (4)