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Testing ISB 2001 for patients with relapsed or refractory multiple myeloma

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

Phase 1 Interventional Ichnos Sciences SA · NCT05862012

This study is testing a new treatment called ISB 2001 to see if it can help people with relapsed or refractory multiple myeloma who haven't had success with other therapies.

Quick facts

PhasePhase 1
Study typeInterventional
Enrollment200 (estimated)
Ages18 Years and up
SexAll
SponsorIchnos Sciences SA Industry-sponsored
Locations32 sites (Palo Alto, California and 31 other locations)
Trial IDNCT05862012 on ClinicalTrials.gov

What this trial studies

This is a first-in-human, Phase 1, open-label study evaluating the safety and anti-myeloma activity of ISB 2001 in patients with relapsed or refractory multiple myeloma. The study consists of two parts: a dose escalation phase to determine the maximum tolerated dose and a dose expansion phase to confirm safety and identify the optimal biologically active dose. Participants will receive ISB 2001 until disease progression, unacceptable toxicity, or withdrawal from the study. The study aims to enroll patients who have previously been treated with established therapies and are refractory or intolerant to them.

Who should consider this trial

Good fit: Ideal candidates are adults with pathologically confirmed relapsed or refractory multiple myeloma who have measurable disease and an ECOG performance status of 2 or less.

Not a fit: Patients with active malignant central nervous system involvement or uncontrolled infections may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients with relapsed or refractory multiple myeloma who have limited alternatives.

How similar studies have performed: Other studies have shown promise with similar approaches in treating multiple myeloma, but this specific treatment is novel.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Palo Alto, California and 31 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Relapsed/Refractory Multiple MyelomaISB 2001Relapsed/refractory multiple myelomaOpen-labelDose escalationDose expansion
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.