NCT05862012

Study of ISB 2001 in Relapsed/Refractory Multiple Myeloma (TRIgnite-1)

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Ichnos Sciences SA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

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

Interventions

Type	Name	Description
DRUG	ISB 2001	Participants receive escalating doses of ISB 2001
DRUG	ISB 2001	Participants receive injection of ISB 2001 as determined in Part 1.

Timeline

• Start date: 2023-11-01
• Primary completion: 2027-07-01
• Completion: 2027-07-01
• First posted: 2023-05-17
• Last updated: 2026-04-01

Locations

32 sites across 7 countries: United States, Australia, France, India, Italy, Norway, Spain

Regulatory

• FDA-regulated drug study