CD123-CAR T

To treat relapsed/refractory CD123+ AML/MDS, B-ALL, T-ALL or BPDCN patient population that needs new cancer-directed therapies.

Cyclophosphamide is a nitrogen mustard derivative. It acts as an alkylating agent that causes cross-linking of DNA strands by binding with nucleic acids and other intracellular structures, thus interfering with the normal function of DNA.

This study will evaluate the safety and maximum tolerated dose of CD123-CAR T cells. This study contains 2 phases. The first part is the called the "Collection and Manufacturing Phase" and the second is the "Treatment Phase". The Collection and Manufacturing Phase refers to your blood cells being collected and possibly frozen, via a process called apheresis. These cells will then be changed to improve their ability to recognize and kill cancer cells.

The CD123-CAR T-cell therapy is a new treatment that is being investigated for treatment of AML/myelodysplastic syndrome (MDS), T- or B- acute lymphoblastic leukemia (ALL) or blastic plasmacytoid dendritic cell neoplasia (BPDCN). The purpose of this study is to find the maximum (highest) dose of CD123-CAR T cells that is safe to give to these patients.

This would include studying the side effects of the chemotherapy, as well as the CD123-CAR T-cell product on the recipient's body, disease and overall survival.

Live record on ClinicalTrials.gov →

• Inclusion Criteria for Procurement and T-cell Production:
• Relapsed/refractory CD123+ disease defined as follows:
• Relapsed disease: Patients developing recurrent disease after a first complete remission (CR)
• Refractory disease: Patients not achieving a CR after 2 cycles of induction chemotherapy
• Relapsed disease that is CD123 positive and CD19 negative/dim or patients otherwise ineligible for CD19 directed therapies including
• Patients in 2nd or greater relapse

Inclusion criteria as written on the registry, trimmed. The full list, with exclusions, is on the live record.