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Mustang Bio: CAR-T Phase 1/2 MB-102 in R/R BPDCN, AML and High Risk MDS - Clinical Trial

What is the Purpose of this Study?

We are doing this study to learn if the study drug (MB-102) can improve treatment results in people with blastic plasmacytoid dendritic cell neoplasm (BPDCN), acute myeloid leukemia (AML) or demethylation-resistant high myelodysplastic syndrome (hrMDS).
What is the Condition Being Studied?
Relapsed or Refractory Blastic Plasmacytoid Dendritic Cell Neoplasm, Acute Myeloid Leukemia, and High Risk Myelodysplastic Syndrome

Who Can Participate in the Study?

Adults who:
-Have BPDCN, AML, high-risk MDS
-Must be able to complete all study visits
-Have not had immunotherapy treatments within 28 days prior to screening
-Have not had previous treatments with anti-CD123 CAR-T treatment.
-Do not have known central nervous system involvement.

Age Group
Adults

What is Involved?

If you choose to join this study, you will:
- Have a screening visit to make sure it is safe for you to be in this study.
- Undergo a process called leukapheresis, which separates the white blood cells.
- Take the study drug (MB-102) which is made out of the white blood cells collected from the leukapheresis
- Get the study drug by IV infusion (into your vein)
- Be admitted to the hospital be fore and at least 3 days after the study drug infusion
- Complete approximately 5 follow-up visits
- You could be in the study for about 3 years.

Study Details

Full Title
A Phase 1/2, Open Label, Multicenter Trial to Assess the Safety and Efficacy of MB-102 in Patients with Relapsed or Refractory Blastic Plasmacytoid Dendritic Cell Neoplasm, Acute Myeloid Leukemia, and High Risk Myelodysplastic Syndrome
Principal Investigator
Cell Therapy and Hematologic Malignancies Specialist
Protocol Number
IRB: PRO00103280
NCT: NCT04109482
Phase
Phase I/II
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698