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CAR T-Cell Therapy MB-102 Granted FDA Orphan Drug Designation for AML

Jason M. Broderick @jasoncology
Published: Wednesday, Jul 24, 2019

Manuel Litchman, MD

Manuel Litchman, MD

The CAR T-Cell therapy MB-102 has been granted an Orphan Drug Designation by the FDA, according to Mustang Bio, Inc, the manufacturer of the investigational treatment.1

“There is increased expression of CD123 on AML blasts, leukemic stem cells and BPDCN cells compared to normal hematopoietic stem cells, and it is therefore a promising target for cellular immunotherapy. We remain encouraged by interim data showing MB-102’s potential to treat BPDCN and AML and continue to evaluate MB-102’s clinical benefits in our ongoing phase I clinical trial,” principal investigator Elizabeth Lihua Budde, MD, PhD, City of Hope, said in a press release at the time the data were presented at the AACR Special Conference.


  1. Mustang Bio Receives Orphan Drug Designation for MB-102 (CD123 CAR T) for the Treatment of Acute Myeloid Leukemia. Mustang Bio. Published July 24, 2019. Accessed July 24, 2019.
  2. Mustang Bio Announces Presentation of MB-102 (CD123 CAR) Safety and Efficacy Data at AACR Special Conference on Tumor Immunology and Immunotherapy. Mustang Bio. Published November 28, 2018. Accessed July 24, 2019.

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