Clinical Trials in Italy / NCT05862012
Recruiting
Phase 1
Study of ISB 2001 in Relapsed/Refractory Multiple Myeloma (TRIgnite-1)
NCT05862012 · tracked via the Priya Life Science Italy tracker
Condition(s) studied
Relapsed/Refractory Multiple Myeloma
Investigational drug(s) / intervention(s)
ISB 2001ISB 2001
ISB 2001: Participants receive escalating doses of ISB 2001
ISB 2001: Participants receive injection of ISB 2001 as determined in Part 1.
Study 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).
Eligibility
Inclusion Criteria:
1. Participants with pathologically confirmed MM with measurable M-protein: serum and/or 24 hour urine, serum-free light chains or measurable isolated plasmacytoma
2. Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less
3. Must have adequate hematologic, hepatic, renal, and cardiac functions
Exclusion Criteria:
1. Active malignant central nervous system involvement
2. Uncontrolled infection requiring systemic antibiotic therapy or other serious infection prior to C1D1
3. History of autoimmune disease requiring systemic immunosuppressive therapy
4. 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.
5. 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.
Primary outcome measure(s)
- 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
Trial sites (32)
| Facility | City | Region | Status |
|---|---|---|---|
| Standford Cancer Institute | Palo Alto | California | Recruiting |
| Sylvester Cancer Center | Miami | Florida | Active Not Recruiting |
| Winship Cancer Institute | Atlanta | Georgia | Recruiting |
| University of Chicago Medical Center | Chicago | Illinois | Recruiting |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | Recruiting |
| Montefiore Medical Center | The Bronx | New York | Recruiting |
| University of North Carolina | Chapel Hill | North Carolina | Recruiting |
| Tennessee Oncology | Nashville | Tennessee | Active Not Recruiting |
| Virginia Commonwealth University (VCU) | Richmond | Virginia | Active Not Recruiting |
| Froedtert Hospital & the Medical College of Wisconsin | Milwaukee | Wisconsin | Recruiting |
| Concord Hospital | Concord | New South Wales | Recruiting |
| Pindara Private Hospital | Benowa | Queensland | Recruiting |
| St. Vincent's Hospital Melbourne | Fitzroy | Victoria | Recruiting |
| Peter MacCallum Cancer Center | Melbourne | Victoria | Recruiting |
| Linear Clinical Research | Nedlands | Western Australia | Recruiting |
| CHRU Lille | Lille | Hauts-de-France | Recruiting |
| CHU Poiters - Hospital la Miletrie | Poitiers | New Aquitaine | Recruiting |
| CHU de Nantes - Hotel Dieu | Nantes | Pays de la Loire Region | Recruiting |
| Groupe Hospitalier Pitie-Salpetriere | Paris | Île-de-France Region | Recruiting |
| Apollo Hospital International Limited | Gandhinagar | Gujarat | Active Not Recruiting |
| Health Care Global Enterprises Ltd. | Bangalore | Karnataka | Active Not Recruiting |
| Deenanath Mangeshkar Hospital and Research Centre | Pune | Maharashta | Active Not Recruiting |
| Apollo Cancer Centers | Hyderabad | Telangana | Active Not Recruiting |
| HCG Hospital | Bangalore | India | Active Not Recruiting |
| ASST Spedali Civili di Brescia | Brescia | Lombardy | Active Not Recruiting |
| Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico | Milan | Lombardy | Recruiting |
| Oslo University Hospital | Oslo | Oslo | Recruiting |
| Instituto de Investigacion Biomedica de Salamanca (IBSAL) | Salamanca | Castile de Leon | Recruiting |
| Institut Catala de Oncologia (ICO) | Badalona | Catalonia | Recruiting |
| Hospital Clinic de Barcelona | Barcelona | Catalonia | Recruiting |
| Centro Integral Oncologici Clara Campal | Madrid | Madrid | Active Not Recruiting |
| Clinica Universidad de Nevarra | Pamplona | Navarre | Recruiting |
Other trials for the same condition
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05862012 on ClinicalTrials.gov ↗ ← All trials in Italy