Study of ISB 2001 for Relapsed/Refractory Multiple Myeloma
This study is testing a drug called ISB 2001 for people with multiple myeloma that has come back or hasn't responded to other treatments (relapsed/refractory multiple myeloma). The main goals are to see how safe ISB 2001 is and what side effects it might cause. Researchers will also look at how well ISB 2001 works against multiple myeloma. You might be able to join if you are 18 or older, have multiple myeloma with measurable M-protein, and have good overall health, including blood, liver, kidney, and heart function. The study is looking to enroll about 200 participants.
- Study design
- This is a Phase 1, open-label study, meaning both you and your doctors will know you are receiving ISB 2001. It will enroll about 200 participants.
- What's involved
- Participants will receive injections of ISB 2001 until their disease gets worse, side effects become too severe, or they withdraw from the study.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your safety will be monitored for up to 18 months after starting treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Study of ISB 2001 in Relapsed/Refractory Multiple Myeloma (TRIgnite-1)
At a glance
Conditions
Where it's being run
32 sites across 29 statesWho to contact
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What this trial measures
- 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