Testing ISB 2001 for patients with relapsed or refractory multiple myeloma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Standford Cancer Institute
  Palo Alto, California, United States Recruiting
• Winship Cancer Institute
  Atlanta, Georgia, United States Recruiting
• University of Chicago Medical Center
  Chicago, Illinois, United States Recruiting
• Beth Israel Deaconess Medical Center
  Boston, Massachusetts, United States Recruiting
• Montefiore Medical Center
  The Bronx, New York, United States Recruiting
• University of North Carolina
  Chapel Hill, North Carolina, United States Recruiting

Study contacts

• Study coordinator: Ichnos Sciences Clinical Trials Administrator
• Email: clinicaltrials@ichnossciences.com
• Phone: (315) 583-1249

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.