CART123 T Cells in Relapsed or Refractory CD123+ Hematologic Malignancies: A Dose Escalation Phase I Trial

Adult patients with refractory or relapsed CD123+ hematologic malignancies, including acute myeloid leukemia, myelodysplastic syndrome, acute lymphoblastic leukemia, or blastic plasmocytoid dentritic cell neoplasm will be recruited in the trial. CART123 cells will be manufatured from blood of each patient. During the production of CAR123 cells, patients may receive appropriate bridging therapy. After cells are produced, participants will undergo a single course of lymphodepleting chemotherapy and receive a single dose of CAR123 T cells. The trial will establish the recommended dose for further studies, either the Maximum Tolerated Dose (MTD) or Maximum Feasible Dose (MFD). Patients must be eligible for hematopoietic stem cell transplantation in order to participate in the trial.

NCT Number	NCT06765876
Lead Sponsor	Institute of Hematology and Blood Transfusion, Czech Republic
Conditions	Leukemia, Myeloid, Acute(AML), Precursor Cell Lymphoblastic Leukemia-Lymphoma, Myelodysplastic Syndromes (MDS), Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)
Enrollment	18 participants
Start Date	2024-10-23
Primary Completion	2028-12-31 (estimated)
Study Completion	2028-12-31 (estimated)
Updated on ClinicalTrials.gov	2026-01-12