Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT05862012

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

Led by Ichnos Sciences SA · Updated on 2026-04-01

200

Participants Needed

32

Research Sites

191 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants with pathologically confirmed multiple myeloma with measurable M-protein in serum, urine, or isolated plasmacytoma
  • Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less
  • Adequate blood, liver, kidney, and heart function
Not Eligible

You will not qualify if you...

  • Active malignant involvement of the central nervous system
  • Uncontrolled infection requiring systemic antibiotics or other serious infection before treatment start
  • History of autoimmune disease needing systemic immunosuppressive therapy
  • Any uncontrolled medical, psychiatric, or social condition that could interfere with study participation or safety
  • Women who are breastfeeding or have a positive pregnancy test at screening or before first dose

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 32 locations

1

Standford Cancer Institute

Palo Alto, California, United States, 94304

Actively Recruiting

2

Sylvester Cancer Center

Miami, Florida, United States, 33136

Active, Not Recruiting

3

Winship Cancer Institute

Atlanta, Georgia, United States, 30322

Actively Recruiting

4

University of Chicago Medical Center

Chicago, Illinois, United States, 60637

Actively Recruiting

5

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States, 02215

Actively Recruiting

6

Montefiore Medical Center

The Bronx, New York, United States, 10467

Actively Recruiting

7

University of North Carolina

Chapel Hill, North Carolina, United States, 27599

Actively Recruiting

8

Tennessee Oncology

Nashville, Tennessee, United States, 37203

Active, Not Recruiting

9

Virginia Commonwealth University (VCU)

Richmond, Virginia, United States, 23298

Active, Not Recruiting

10

Froedtert Hospital & the Medical College of Wisconsin

Milwaukee, Wisconsin, United States, 53226

Actively Recruiting

11

Concord Hospital

Concord, New South Wales, Australia, 2139

Actively Recruiting

12

Pindara Private Hospital

Benowa, Queensland, Australia, 4217

Actively Recruiting

13

St. Vincent's Hospital Melbourne

Fitzroy, Victoria, Australia, 3065

Actively Recruiting

14

Peter MacCallum Cancer Center

Melbourne, Victoria, Australia, 3000

Actively Recruiting

15

Linear Clinical Research

Nedlands, Western Australia, Australia, 6009

Actively Recruiting

16

CHRU Lille

Lille, Hauts-de-France, France, 59800

Actively Recruiting

17

CHU Poiters - Hospital la Miletrie

Poitiers, New Aquitaine, France, 86021

Actively Recruiting

18

CHU de Nantes - Hotel Dieu

Nantes, Pays de la Loire Region, France, 44093

Actively Recruiting

19

Groupe Hospitalier Pitie-Salpetriere

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

Actively Recruiting

20

Apollo Hospital International Limited

Gandhinagar, Gujarat, India, 382428

Active, Not Recruiting

21

Health Care Global Enterprises Ltd.

Bangalore, Karnataka, India, 560027

Active, Not Recruiting

22

Deenanath Mangeshkar Hospital and Research Centre

Pune, Maharashta, India, 411004

Active, Not Recruiting

23

Apollo Cancer Centers

Hyderabad, Telangana, India, 500033

Active, Not Recruiting

24

HCG Hospital

Bangalore, India

Active, Not Recruiting

25

ASST Spedali Civili di Brescia

Brescia, Lombardy, Italy, 25123

Active, Not Recruiting

26

Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico

Milan, Lombardy, Italy, 20122

Actively Recruiting

27

Oslo University Hospital

Oslo, Oslo, Norway, 0372

Actively Recruiting

28

Instituto de Investigacion Biomedica de Salamanca (IBSAL)

Salamanca, Castile de Leon, Spain, 37007

Actively Recruiting

29

Institut Catala de Oncologia (ICO)

Badalona, Catalonia, Spain, 08916

Actively Recruiting

30

Hospital Clinic de Barcelona

Barcelona, Catalonia, Spain, 08036

Actively Recruiting

31

Centro Integral Oncologici Clara Campal

Madrid, Madrid, Spain, 28050

Active, Not Recruiting

32

Clinica Universidad de Nevarra

Pamplona, Navarre, Spain, 31008

Actively Recruiting

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Research Team

I

Ichnos Sciences Clinical Trials Administrator

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

2

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