Study of ISB 2001 in Relapsed/Refractory Multiple Myeloma (TRIgnite-1)
ConditionRelapsed/Refractory Multiple Myeloma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorIchnos Sciences SA
About this trial
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
Qualifiers
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- ISB 2001
- ISB 2001
Treatment groups
200 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov