BSB-2002 After Cyclophosphamide and Fludarabine for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia Patients With NPM1 Mutation

Study Summary

This phase I trial studies the side effects and best dose of BSB-2002 when given after cyclophosphamide and fludarabine and tests how well it works in treating NPM1-mutated acute myeloid leukemia (AML) that has come back after a period of improvement (relapsed) or that does not respond to treatment (refractory). BSB-2002 is a type of personalized autologous T cell receptor-modified T cell therapy. T cells are infection fighting blood cells that can kill cancer cells. The T cells given in this study come from the patient and have a new gene put in them that makes them able to recognize mutated NPM1, a protein on the surface of cancer cells. These NPM1 mutated-specific T cells may help the body's immune system identify and kill NPM1-mutated AML cells. Giving chemotherapy, such as cyclophosphamide and fludarabine, before BSB-2002 helps kill cancer cells in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow. Giving BSB-2002 after cyclophosphamide and fludarabine may be safe, tolerable, and/or effective in treating relapsed or refractory AML in patients with NPM1 mutation.

Primary Outcome

Dose-limiting toxicity (DLT) will be assessed using the National Cancer Institute (NCI)'s Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Adverse events will be coded according to the Medical Dictionary for Regulatory Activities. Each adverse event will be counted once per patient. Separate tables and listings will present treatment-emergent adverse events (TEAEs), Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESI), and dose-limiting toxicities (DLT). Ta

Interventions

• DRUG Cyclophosphamide
• PROCEDURE Biospecimen Collection
• PROCEDURE Bone Marrow Aspiration
• PROCEDURE Bone Marrow Biopsy
• PROCEDURE Echocardiography Test