City of Hope Medical Center
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 OBJECTIVE: I. Evaluate the safety of BSB-2002. SECONDARY OBJECTIVES: I. Cellular kinetics of BSB-2002 in peripheral blood through day 365. II. Evaluate the efficacy of BSB-2002 based on IIa. Percentage of patients with complete remission (CR; including CR with measurable residual disease negative \[CRMRD-\], CR, CR with incomplete hematologic recovery \[CRi\], CR with partial hematologic recovery \[CRh\]) or partial remission (PR) as determined by the investigator according to the European LeukemiaNet (ELN) criteria for AML; IIb. Overall survival; IIc. Duration of response (time fro…
Inclusion Criteria: * Documented informed consent of the participant * Note: For research participants who do not speak English, a short form consent may be used with a City of Hope (COH) certified interpreter/translator to proceed with screening, while the request for a translated full consent is processed * Age: ≥ 18 years * HLA-A\*02:01 * Eastern Cooperative Oncology Group (ECOG) ≤ 2 * Adequate venous access for apheresis or agree to use of a central line for apheresis collection * AML diagnosed per ELN criteria which has been treated with at least two lines of therapy, and meet one of…
Undergo blood sample collection
Undergo bone marrow aspiration
Undergo bone marrow biopsy
Given IV
Undergo echocardiography
Given IV
Undergo leukapheresis
Given BSB-2002 IV