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New treatment option for Relapsed/Refractory Multiple Myeloma
Official title Study of ISB 2001 in Relapsed/Refractory Multiple Myeloma (TRIgnite-1)
ClinicalTrials.gov ID: NCT05862012
What this study is testing
What is ISB 2001?
ISB 2001 is an investigational medicine, being studied as a potential treatment for relapsed/refractory multiple myeloma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participants with pathologically confirmed MM with measurable M-protein: serum and/or 24 hour urine, serum-free light chains or measurable isolated...
- Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less
- Must have adequate hematologic, hepatic, renal, and cardiac functions
You likely can't join if
- 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...
- Female people who are lactating and breastfeeding or have a positive pregnancy test during the screening period or on Day 1 before first dose of ISB...
The study team makes the final eligibility decision.
Where it's taking place
- Palo Alto, California, United States
- Miami, Florida, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Boston, Massachusetts, United States
- The Bronx, New York, United States
- Chapel Hill, North Carolina, United States
- Nashville, Tennessee, United States
- Richmond, Virginia, United States
- Milwaukee, Wisconsin, United States
- Concord, New South Wales, Australia
- Benowa, Queensland, Australia
- Fitzroy, Victoria, Australia
- Melbourne, Victoria, Australia
- Nedlands, Western Australia, Australia
- Lille, Hauts-de-France, France
- Poitiers, New Aquitaine, France
- Nantes, Pays de la Loire Region, France
- Paris, Île-de-France Region, France
- Gandhinagar, Gujarat, India
+ 12 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Palo Alto, California, United States; Miami, Florida, United States; Atlanta, Georgia, United States; Chicago, Illinois, United States; Boston, Massachusetts, United States; The Bronx, New York, United States and 26 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.