NCT05862012 Study of ISB 2001 in Relapsed/Refractory Multiple Myeloma (TRIgnite-1)
| NCT ID | NCT05862012 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Ichnos Sciences SA |
| Condition | Relapsed/Refractory Multiple Myeloma |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2023-11-01 |
| Primary Completion | 2027-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 200 participants in total. It began in 2023-11-01 with a primary completion date of 2027-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05862012 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Relapsed/Refractory Multiple Myeloma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05862012 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05862012 currently recruiting?
Yes, NCT05862012 is actively recruiting participants. Contact the research team at clinicaltrials@ichnossciences.com for enrollment information.
Where is the NCT05862012 trial being conducted?
This trial is being conducted at Palo Alto, United States, Miami, United States, Atlanta, United States, Chicago, United States and 11 additional locations.
Who is sponsoring the NCT05862012 clinical trial?
NCT05862012 is sponsored by Ichnos Sciences SA. The trial plans to enroll 200 participants.