What this study is
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).
What's being tested
- ISB 2001
Intervention · DRUG
Participants receive escalating doses of ISB 2001
- ISB 2001
Intervention · DRUG
Participants receive injection of ISB 2001 as determined in Part 1.
Study details
- Official title
- A Phase 1, First-in-Human, Multicenter, Open-Label, Dose Escalation and Dose-Expansion Study of Single-Agent ISB 2001 in Subjects With Relapsed/Refractory Multiple Myeloma
- Sponsor
- Ichnos Sciences SA
- Conditions
- Relapsed/Refractory Multiple Myeloma
- Enrolling
- 200 people
- Starts
- 2023-11-01
- Est. completion
- 2027-07
- Design
- Open-label, randomized, sequential groups, Phase 1
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou 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 can't join 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (32)
22 openStandford Cancer Institute
Palo Alto, California, United States
- Michaela Liedtke · Contact650-723-0501mliedtke@stanford.edu
RecruitingWinship Cancer Institute
Atlanta, Georgia, United States
- Nishi Shah, MD · Contact404-778-0659nishi.nilesh@emory.edu
RecruitingUniversity of Chicago Medical Center
Chicago, Illinois, United States
- Benjamin Derman, MD · Contact8472758131bendermanmd@gmail.com
RecruitingBeth Israel Deaconess Medical Center
Boston, Massachusetts, United States
- Shonali Midha, MD · Contact617-632-2104shonali_midha@dfci.harvard.edu
RecruitingMontefiore Medical Center
The Bronx, New York, United States
- David Levitz · Contact860-918-6192dlevitz@montefiore.org
RecruitingUniversity of North Carolina
Chapel Hill, North Carolina, United States
- Eben Lichtman · Contact6178426051eben_lichtman@med.unc.edu
RecruitingFroedtert Hospital & the Medical College of Wisconsin
Milwaukee, Wisconsin, United States
- Binod Dhakal, MD · Contact4148054600bdhakal@mcw.edu
RecruitingSylvester Cancer Center
Miami, Florida, United States
Active, not recruitingTennessee Oncology
Nashville, Tennessee, United States
Active, not recruitingVirginia Commonwealth University (VCU)
Richmond, Virginia, United States
Active, not recruiting
22 sites outside the US
Concord Hospital
Concord, New South Wales, Australia
- Nicole Wong Doo · Contact+61 2 9767 7243nicole.wongdoo@health.nsw.gov.au
RecruitingPindara Private Hospital
Benowa, Queensland, Australia
- Hanlon Sia, MBBS(Adelaide), FRACP, FRCPA · Contactdrsia@fiho.com.au
RecruitingSt. Vincent's Hospital Melbourne
Fitzroy, Victoria, Australia
- Hang Quach · Contact03 9231 2003hang.quach@svha.org.au
RecruitingPeter MacCallum Cancer Center
Melbourne, Victoria, Australia
- Amit Khot · Contact+6138559500Amit.Khot@petermac.org
RecruitingLinear Clinical Research
Nedlands, Western Australia, Australia
- Bradley Augustston · Contact+61 (0) 8 6382 5100bradley.augustson@health.wa.gov.au
RecruitingCHRU Lille
Lille, Hauts-de-France, France
- Salomon Manier, MD · Contact+33-320444292salomon.manier@chru-lille.fr
RecruitingCHU Poiters - Hospital la Miletrie
Poitiers, Nouvelle-Aquitaine, France
- Xavier Leleu, MD · Contact+33-240083271xavier.leleu@chu-poitiers.fr
RecruitingCHU de Nantes - Hotel Dieu
Nantes, Pays de la Loire Region, France
- Cyrille Touzeau, MD · Contact+33-240083271cyrille.touzeau@chu-nantes.fr
RecruitingGroupe Hospitalier Pitie-Salpetriere
Paris, Île-de-France Region, France
- Laurent Garderet, MD · Contact+33-611010920laurent.garderet@aphp.fr
RecruitingFondazione IRCCS CA' Granda Ospedale Maggiore Policlinico
Milan, Lombardy, Italy
- Matteo Da Via · Contact+39-255033421matteo.davia@policlinico.mi.it
RecruitingOslo University Hospital
Oslo, Oslo County, Norway
- Fredrik Schjesvild, MD · Contact+47-02770fredrikschjesvold@gmail.com
RecruitingInstituto de Investigacion Biomedica de Salamanca (IBSAL)
Salamanca, Castile de Leon, Spain
- Maria-Victoria Mateos, MD · Contact+34-923291100mvmateos@usal.es
RecruitingInstitut Catala de Oncologia (ICO)
Badalona, Catalonia, Spain
- Laura Abril, MD · Contact+34-934978706labril@iconcologia.net
RecruitingHospital Clinic de Barcelona
Barcelona, Catalonia, Spain
- Laura Rosinol, MD · Contact+34-932275428lrosinol@clinic.cat
RecruitingClinica Universidad de Nevarra
Pamplona, Navarre, Spain
- Paula Rodriguez Otero, MD · Contact+34-948296397paurodriguez@unav.es
RecruitingApollo Hospital International Limited
Gandhinagar, Gujarat, India
Active, not recruitingHealth Care Global Enterprises Ltd.
Bangalore, Karnataka, India
Active, not recruitingDeenanath Mangeshkar Hospital and Research Centre
Pune, Maharashta, India
Active, not recruitingApollo Cancer Centers
Hyderabad, Telangana, India
Active, not recruitingHCG Hospital
Bangalore, India
Active, not recruitingASST Spedali Civili di Brescia
Brescia, Lombardy, Italy
Active, not recruitingCentro Integral Oncologici Clara Campal
Madrid, Madrid, Spain
Active, not recruiting
Study team
Sponsor
Ichnos Sciences SA
Study ID ISB 2001-101
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.