Safety and Dose Finding of Autologous CART123 T Cells for Adults with Relapsed or Refractory CD123 Blood Cancers Including AML, MDS, ALL, or BPDCN

What this Trial Is About

Researchers are evaluating a new treatment for adult patients with relapsed or refractory CD123-positive blood cancers, including acute myeloid leukemia, myelodysplastic syndrome, acute lymphoblastic leukemia, and blastic plasmacytoid dendritic cell neoplasm. This early-phase trial aims to find the recommended dose of CAR123 T cells, a type of genetically modified immune cell therapy, and assess its safety and tolerability. Participants must be eligible for hematopoietic stem cell transplantation and have a suitable donor identified before receiving the therapy. Patients will have their own blood used to create CAR123 T cells, which will be given back after a single course of chemotherapy to reduce their existing immune cells. The dose of CAR123 cells will be increased in steps to determine the highest safe or feasible dose. During cell manufacturing, patients may receive bridging treatments if needed. The study is open-label and involves one treatment group receiving autologous CAR123 T lymphocytes. The decision to perform stem cell transplantation after treatment will be individualized. Throughout the trial, participants will be monitored for safety and recovery of blood cells at multiple time points up to 24 months. Researchers will assess the recommended dose, response to treatment, survival, and the need for stem cell transplantation. Blood tests, disease assessments, and follow-up visits will be conducted regularly to evaluate outcomes and detect any side effects. The total duration of participant involvement can extend to two years for safety and efficacy follow-up.

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