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Relapsed/Refractory Multiple MyelomaPhase 1NCT05862012

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

A Phase 1 study testing ISB 2001 in people with Relapsed/Refractory Multiple Myeloma, run by Ichnos Sciences SA at 32 sites in 7 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Relapsed/Refractory Multiple Myeloma
What is being tested?
ISB 2001
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
32 sitesin 7 countries
Study dates
1 Nov 2023to Jul 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

32 sites in 7 countries. Contact the study team or a site near you to ask about taking part.

Ichnos Sciences Clinical Trials Administrator contact

(315) 583-1249

clinicaltrials@ichnossciences.com

32 sites in 7 countries

United States10 sites, 7 recruiting

  • Winship Cancer Institute

    Atlanta, Georgia, 30322

    Nishi Shah, MD, 404-778-0659, nishi.nilesh@emory.edu

    Recruiting

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

    Shonali Midha, MD, 617-632-2104, shonali_midha@dfci.harvard.edu

    Recruiting

  • University of North Carolina

    Chapel Hill, North Carolina, 27599

    Eben Lichtman, 6178426051, eben_lichtman@med.unc.edu

    Recruiting

  • University of Chicago Medical Center

    Chicago, Illinois, 60637

    Benjamin Derman, MD, 8472758131, bendermanmd@gmail.com

    Recruiting

  • Sylvester Cancer Center

    Miami, Florida, 33136

    Active, not recruiting

  • Froedtert Hospital & the Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

    Binod Dhakal, MD, 4148054600, bdhakal@mcw.edu

    Recruiting

  • Tennessee Oncology

    Nashville, Tennessee, 37203

    Active, not recruiting

  • Standford Cancer Institute

    Palo Alto, California, 94304

    Michaela Liedtke, 650-723-0501, mliedtke@stanford.edu

    Recruiting

  • Virginia Commonwealth University (VCU)

    Richmond, Virginia, 23298

    Active, not recruiting

  • Montefiore Medical Center

    The Bronx, New York, 10467

    David Levitz, 860-918-6192, dlevitz@montefiore.org

    Recruiting

Other trials in United States

Australia5 sites, 5 recruiting

  • Pindara Private Hospital

    Benowa, Queensland, 4217

    Hanlon Sia, MBBS(Adelaide), FRACP, FRCPA, drsia@fiho.com.au

    Recruiting

  • Concord Hospital

    Concord, New South Wales, 2139

    Nicole Wong Doo, +61 2 9767 7243, nicole.wongdoo@health.nsw.gov.au

    Recruiting

  • St. Vincent's Hospital Melbourne

    Fitzroy, Victoria, 3065

    Hang Quach, 03 9231 2003, hang.quach@svha.org.au

    Recruiting

  • Peter MacCallum Cancer Center

    Melbourne, Victoria, 3000

    Amit Khot, +6138559500, Amit.Khot@petermac.org

    Recruiting

  • Linear Clinical Research

    Nedlands, Western Australia, 6009

    Bradley Augustston, +61 (0) 8 6382 5100, bradley.augustson@health.wa.gov.au

    Recruiting

Other trials in Australia

India5 sites

  • Health Care Global Enterprises Ltd.

    Bangalore, Karnataka, 560027

    Active, not recruiting

  • HCG Hospital

    Bangalore

    Active, not recruiting

  • Apollo Hospital International Limited

    Gandhinagar, Gujarat, 382428

    Active, not recruiting

  • Apollo Cancer Centers

    Hyderabad, Telangana, 500033

    Active, not recruiting

  • Deenanath Mangeshkar Hospital and Research Centre

    Pune, Maharashta, 411004

    Active, not recruiting

Other trials in India

Spain5 sites, 4 recruiting

  • Institut Catala de Oncologia (ICO)

    Badalona, Catalonia, 08916

    Laura Abril, MD, +34-934978706, labril@iconcologia.net

    Recruiting

  • Hospital Clinic de Barcelona

    Barcelona, Catalonia, 08036

    Laura Rosinol, MD, +34-932275428, lrosinol@clinic.cat

    Recruiting

  • Centro Integral Oncologici Clara Campal

    Madrid, Madrid, 28050

    Active, not recruiting

  • Clinica Universidad de Nevarra

    Pamplona, Navarre, 31008

    Paula Rodriguez Otero, MD, +34-948296397, paurodriguez@unav.es

    Recruiting

  • Instituto de Investigacion Biomedica de Salamanca (IBSAL)

    Salamanca, Castile de Leon, 37007

    Maria-Victoria Mateos, MD, +34-923291100, mvmateos@usal.es

    Recruiting

Other trials in Spain

France4 sites, 4 recruiting

  • CHRU Lille

    Lille, Hauts-de-France, 59800

    Salomon Manier, MD, +33-320444292, salomon.manier@chru-lille.fr

    Recruiting

  • CHU de Nantes - Hotel Dieu

    Nantes, Pays de la Loire Region, 44093

    Cyrille Touzeau, MD, +33-240083271, cyrille.touzeau@chu-nantes.fr

    Recruiting

  • Groupe Hospitalier Pitie-Salpetriere

    Paris, Île-de-France Region, 75013

    Laurent Garderet, MD, +33-611010920, laurent.garderet@aphp.fr

    Recruiting

  • CHU Poiters - Hospital la Miletrie

    Poitiers, New Aquitaine, 86021

    Xavier Leleu, MD, +33-240083271, xavier.leleu@chu-poitiers.fr

    Recruiting

Other trials in France

Italy2 sites, 1 recruiting

  • ASST Spedali Civili di Brescia

    Brescia, Lombardy, 25123

    Active, not recruiting

  • Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico

    Milan, Lombardy, 20122

    Matteo Da Via, +39-255033421, matteo.davia@policlinico.mi.it

    Recruiting

Other trials in Italy

Norway1 site, 1 recruiting

  • Oslo University Hospital

    Oslo, Oslo, 0372

    Fredrik Schjesvild, MD, +47-02770, fredrikschjesvold@gmail.com

    Recruiting

Other trials in Norway

About this study

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

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).

Read the detailed description

The study enrolls participants with R/R MM that have been treated with immunomodulatory drugs (IMiDs), proteasome inhibitors, and anti-CD38 therapies either in combination or as a single agent and are refractory to, or intolerant of, established therapies known to provide clinical benefit in MM.

The study is conducted in two parts: Part 1 dose escalation and Part 2 dose expansion.

Dose escalation continued until the maximum planned dose was reached. Dose expansion cohorts were initiated to further confirm safety and optimal biologically active dose. Participants receive ISB 2001 until disease progression, unacceptable toxicity occurs, any criterion for stopping the study treatment, or participant withdrawal from the study.

Being tested
ISB 2001
Keywords
ISB 2001, Relapsed/refractory multiple myeloma, Open-label, Dose escalation, Dose expansion
Medical subject headings
Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ISB 2001Drug

    Participants receive escalating doses of ISB 2001

  • ISB 2001Drug

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

Study groups in NCT05862012
Study groupRoleWhat they receive
Part 1: Dose EscalationExperimentalParticipants 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
Receives: Drug: ISB 2001
Part 2: Dose ExpansionExperimentalDose 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.
Receives: Drug: ISB 2001

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Up to 18 months

  2. 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)

    Measured: Up to 28 days

Secondary outcomes (13)

  1. Maximum Concentration (Cmax) of ISB 2001 in Serum

    Measured: Up to 28 days

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

    Measured: Up to 28 days

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

    Measured: Up to 28 days

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

    Measured: Up to 28 days

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

    Measured: Baseline to 18 months

  6. Overall Response Rate (ORR) Based on International Myeloma Working Group (IMWG)

    Measured: 18 months

  7. Complete Response Rate (CRR) Based on International Myeloma Working Group (IMWG)

    Measured: 18 months

  8. Duration of Response (DOR) Based on International Myeloma Working Group (IMWG)

    Measured: 18 months

  9. Time to Progression (TTP)

    Measured: 18 months

  10. Time to Next Treatment (TTNT)

    Measured: 18 months

  11. Time to Response (TTR)

    Measured: 18 months

  12. Progression Free Survival (PFS)

    Measured: 18 months

  13. Overall Survival (OS)

    Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 May 2023
  2. Study start1 Nov 2023
  3. Primary completionJul 2027 (estimated)
  4. Study completionJul 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05862012
Sponsor's protocol ID
ISB 2001-101
Status last verified
Mar 2026
First submitted
4 May 2023
Last updated
1 Apr 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Chandralayam Ayyappa Menon V, Matsuura T, Holkova B, Gudi GS, Drake A, Pihlgren M, van der Graaf PH, Gn S, Garton A, Perro M, Konto C, Pacaud L. Clinical Validation of a QSP Model for ISB 2001, a Trispecific T Cell Engager to Support Optimal FIH Study Design in RRMM Patients. Clin Pharmacol Ther. 2026 Aug;120(2):452-464. doi: 10.1002/cpt.70319. Epub 2026 May 28.

    PubMed 42206665

  • 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.

    PubMed 39261676

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ISB 2001 in people with Relapsed/Refractory Multiple Myeloma, run by Ichnos Sciences SA at 32 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 32 sites in United States, Australia, India, Spain, France and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ichnos Sciences Clinical Trials Administrator ((315) 583-1249, clinicaltrials@ichnossciences.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Frequency and Severity Of Treatment-Emergent Adverse Events (TEAEs) (time frame: Up to 18 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05862012, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.

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