This phase Ib trial tests how well brexucabtagene autoleucel and dasatinib work in treating patients with B acute lymphoblastic leukemia that has come back after a period of improvement (relapsed) or that does not respond to treatment or that has not responded to previous treatment (refractory). Brexucabtagene autoleucel injection is in a class of medications called autologous cellular immunotherapy, a type of medication prepared using cells from the patient's own blood. It works by causing the body's immune system (a group of cells, tissues, and organs that protects the body from attack by bacteria, viruses, cancer cells, and other substances that cause disease) to fight the cancer cells. Dasatinib is in a class of medications called tyrosine kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply, which may help keep cancer cells from growing. Giving brexucabtagene autoleucel followed by dasatinib may work better in treating patients with B acute lymphoblastic leukemia.
Additional locations may be listed on ClinicalTrials.gov for NCT05993949.
Locations matching your search criteria
United States
California
Palo Alto
Stanford Cancer Institute Palo AltoStatus: Active
Contact: Lori Samantha Muffly
Phone: 650-245-1444
PRIMARY OBJECTIVE:
I. Assess the feasibility of oral dasatinib pulses (3 consecutive days per week) during the first month following infusion of brexucabtagene autoleucel (Tecartus) in adults with relapsed or refractory B-cell acute lymphoblastic leukemia.
SECONDARY OBJECTIVES:
I. To evaluate the safety of oral dasatinib pulses post Tecartus infusion.
II. To evaluate response rate at one and three months following Tecartus plus dasatinib.
III. To evaluate duration of response up to one year following Tecartus plus dasatinib.
IV. To analyze progression-free (PFS) and overall (OS) survival following Tecartus plus dasatinib up to two up to one years following Tecartus plus dasatinib.
OUTLINE:
Patients undergo leukapheresis on study. Patients receive fludarabine intravenously (IV) over 30 minutes on days -4 to -2, cyclophosphamide IV over 60 minutes on day -2, and brexucabtagene autoleucel IV on day 0. Patients then receive dasatinib orally (PO) once daily (QD) on days 4-6, 11-13, and 18-20 in the absence of disease progression or unacceptable toxicity. Patients may also undergo echocardiography (ECHO) or multigated acquisition scan (MUGA) at screening and undergo bone marrow aspiration, collection of blood samples, lumbar puncture, and magnetic resonance imaging (MRI) and/or positron emission tomography (PET)/computed tomography (CT) throughout the trial.
After completion of study treatment, patients are followed up at day 28, months 2, 3, 6, 9, and 12, every 6-12 months until year 2, and then annually in years 2-15.
Lead OrganizationStanford Cancer Institute Palo Alto
Principal InvestigatorLori Samantha Muffly