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.
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
32 sites in 7 countries
United States10 sites, 7 recruiting
- 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
- Active, not recruiting
Sylvester Cancer Center
Miami, Florida, 33136
- Recruiting
Froedtert Hospital & the Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Binod Dhakal, MD, 4148054600, bdhakal@mcw.edu
- Active, not recruiting
Tennessee Oncology
Nashville, Tennessee, 37203
- Recruiting
Standford Cancer Institute
Palo Alto, California, 94304
Michaela Liedtke, 650-723-0501, mliedtke@stanford.edu
- Active, not recruiting
Virginia Commonwealth University (VCU)
Richmond, Virginia, 23298
- Recruiting
Montefiore Medical Center
The Bronx, New York, 10467
David Levitz, 860-918-6192, dlevitz@montefiore.org
Australia5 sites, 5 recruiting
- 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
India5 sites
- Active, not recruiting
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
Spain5 sites, 4 recruiting
- 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
- Active, not recruiting
Centro Integral Oncologici Clara Campal
Madrid, Madrid, 28050
- 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
France4 sites, 4 recruiting
- 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
Italy2 sites, 1 recruiting
- Active, not recruiting
ASST Spedali Civili di Brescia
Brescia, Lombardy, 25123
- Recruiting
Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico
Milan, Lombardy, 20122
Matteo Da Via, +39-255033421, matteo.davia@policlinico.mi.it
Norway1 site, 1 recruiting
- Recruiting
Oslo University Hospital
Oslo, Oslo, 0372
Fredrik Schjesvild, MD, +47-02770, fredrikschjesvold@gmail.com
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.
- Conditions
- Relapsed/Refractory Multiple Myeloma
- 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 group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Drug: ISB 2001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency and Severity Of Treatment-Emergent Adverse Events (TEAEs)
Measured: 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)
Measured: Up to 28 days
Secondary outcomes (13)
Maximum Concentration (Cmax) of ISB 2001 in Serum
Measured: Up to 28 days
Time to Reach Maximum Concentration (Tmax) of ISB 2001 in Serum
Measured: Up to 28 days
Area Under the Concentration Time Curve in Dosing Intervals (AUC0-tau) of ISB 2001 in Serum
Measured: Up to 28 days
Area Under the Concentration Time Curve From Zero to Time t (AUC0-t) of ISB 2001 in Serum
Measured: 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)
Measured: Baseline to 18 months
Overall Response Rate (ORR) Based on International Myeloma Working Group (IMWG)
Measured: 18 months
Complete Response Rate (CRR) Based on International Myeloma Working Group (IMWG)
Measured: 18 months
Duration of Response (DOR) Based on International Myeloma Working Group (IMWG)
Measured: 18 months
Time to Progression (TTP)
Measured: 18 months
Time to Next Treatment (TTNT)
Measured: 18 months
Time to Response (TTR)
Measured: 18 months
Progression Free Survival (PFS)
Measured: 18 months
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.
- First posted17 May 2023
- Study start1 Nov 2023
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Relapsed/Refractory Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Ichnos Sciences SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
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 42206665Carretero-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
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05862012
- Acronym / sponsor ID
- ISB 2001-101
- Conditions
- Relapsed/Refractory Multiple Myeloma
- Keywords
- ISB 2001, Relapsed/refractory multiple myeloma, Open-label, Dose escalation, Dose expansion
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Ichnos Sciences SAIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 17 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part 1: Dose Escalation | Experimental | Drug: ISB 2001Participants 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 |
| Part 2: Dose Expansion | Experimental | Drug: ISB 2001Dose 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ISB 2001Participants receive escalating doses of ISB 2001 | Drug | Part 1: Dose Escalation |
| ISB 2001Participants receive injection of ISB 2001 as determined in Part 1. | Drug | Part 2: Dose Expansion |
Primary outcome
Frequency and Severity Of Treatment-Emergent Adverse Events (TEAEs)
Time frame: 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)
Time frame: Up to 28 days
13 secondary outcomes
Maximum Concentration (Cmax) of ISB 2001 in Serum
Time frame: Up to 28 days
Time to Reach Maximum Concentration (Tmax) of ISB 2001 in Serum
Time frame: Up to 28 days
Area Under the Concentration Time Curve in Dosing Intervals (AUC0-tau) of ISB 2001 in Serum
Time frame: Up to 28 days
Area Under the Concentration Time Curve From Zero to Time t (AUC0-t) of ISB 2001 in Serum
Time frame: 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)
Time frame: Baseline to 18 months
Overall Response Rate (ORR) Based on International Myeloma Working Group (IMWG)
Time frame: 18 months
Complete Response Rate (CRR) Based on International Myeloma Working Group (IMWG)
Time frame: 18 months
Duration of Response (DOR) Based on International Myeloma Working Group (IMWG)
Time frame: 18 months
Time to Progression (TTP)
Time frame: 18 months
Time to Next Treatment (TTNT)
Time frame: 18 months
Time to Response (TTR)
Time frame: 18 months
Progression Free Survival (PFS)
Time frame: 18 months
Overall Survival (OS)
Time frame: 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
- Derived from this study: PubMed 42206665Chandralayam 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.
- Derived from this study: PubMed 39261676Carretero-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ichnos Sciences Clinical Trials Administrator contact
32 sites in 7 countries: see every site and its status.
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.