Ichnos: Ph1 Multi Open 2 part Dose Esc / Exp Single Agent ISB 1342 PTMM - Clinical Trial

What is the Purpose of this Study?

We are doing this study to find out if an experimental drug called ISB 1342 (study drug) is a safe and effective treatment for people with MM.

What is the Condition Being Studied?

Multiple Myeloma (MM)

Who Can Participate in the Study?

Adults diagnosed with MM who:
- Were previously treated with study therapy that might include proteasome inhibitors, immunomodulators, or anti-CD38 targeted therapies (e.g., daratumumab or isatuximab)
- Did not respond to the previous treatment or had their cancer come back

For more information about who can join this study, please contact the study team at 919-684-9220.

Age Group
Adults

What is Involved?

If you choose to join this study, you will go through a screening period to find out if you are eligible. During this screening period, you will:
- Have a physical exam
- Have a heart scan (ECG)
- Have blood draws and give urine samples
- Have bone marrow samples taken
- Have whole-body X-rays and MRI or CT scans

If you are eligible to continue in the study after screening, you will get a dose of the study drug once a week for each drug cycle. Each drug cycle lasts 4 weeks. Your number of drug cycles will depend on your study doctor's assessment of how you are doing.

You will continue to visit our clinic for check-up visits to see how you are doing after you stop taking the study drug.

Study Details

Full Title
A Phase 1, First-in-Human, Multicenter, Open-Label, Two Part Dose-Escalation and Cohort Expansion Study of Single-Agent ISB 1342 in Subjects with Previously Treated Multiple Myeloma
Principal Investigator
Cellular Therapy Specialist
Protocol Number
IRB: PRO00103895
NCT: NCT03309111
Phase
Phase I
ClinicalTrials.gov
Enrollment Status
Open for Enrollment
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698