Study Details

Open

Study of ISB 2001 in Relapsed/Refractory Multiple Myeloma

The purpose of this study is to see if an experimental drug called ISB 2001 is safe and well-tolerated in patients with multiple myeloma. This study will also help us learn more about the drug and how it works with your body. We want to learn more about the best dose, how much of the drug enters the blood, and if it can be used in the treatment of multiple myeloma.

Age & Gender

18 years ~ 99 years
Male, Female, Gender Inclusive

Visit Availability

Standard business hours (M-F, 8-5)
Visits can be combined with regular clinical appointments

Location

North Carolina (Statewide)

What will be asked of you

We will first ask you some questions and do some tests to make sure you are able to take part, including bone marrow aspiration and/or bone marrow biopsy, archival tumor tissue acquisition, whole-body PET-CT or MRI scans, and x-rays. If you can take part, treatment will involve giving the drug once weekly, exams and tests, and blood and urine samples. At the end of treatment, we will run more scans and tests.

Incentives

ISB 2001 will be made available to you at no charge, and you will not be required to pay for any study procedures.

Total length of participation:
3-6 months or more

Looking for Specific Volunteers

Able to participate:

You have confirmed multiple myeloma with measurable M-protein or measurable isolated plasmacytoma.
You are considered relapsed/refractory to at least three prior lines of treatment.
You have a life expectancy of at least three months.
You have adequate hematologic and organ function per study lab criteria.
You have recovered to Grade 1 or baseline from any toxicity related to previous therapy.

Not eligible if:

You are participating in another interventional study within four weeks of starting study treatment.
You have active central nervous system cancer involvement.
You have known history of HIV infection or any other relevant congentital or acquired immunodeficiency.
You have a history of any serious cardiovascular events within six months of study treatment per protocol.
You have any history of autoimmune disease requiring immunosuppressive therapy.

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Lineberger Clinical Trials Office
cancerclinicaltrials@med.unc.edu
(919) 966-4432

Primary Visit Location

NC Cancer Hospital (Basnight)
UNC Hospitals / UNC Medical Center
101 Manning Dr, Chapel Hill, NC 27514, USA

Secondary Visit Location

UNC Hospitals Hillsborough Campus
460 Waterstone Dr, Hillsborough, NC 27278, USA

Additional Study Information

Principal Investigator

Eben Lichtman
LCCC - Clinical Trials

Study Type

Clinical or Medical
Interventional

Study Topics

Cancer (Multiple Myeloma)

IRB Number

23-1873

ClinicalTrials.gov

NCT05862012