The goal of this clinical trial is to test BSB-2002 which is a new type of cellular therapy to treat blood cancer (AML). It will evaluate the safety of BSB-2002 and also determine whether it works to prevent relapse of your cancer.
This is a Phase I, multicenter, open-label, non-randomized study to characterize the safety and clinical activity of BSB-2002, a genetically modified autologous T cell product incorporating an HLA-A\*02:01-restricted mutant NPM1-directed T cell receptor (TCR), administered to patients with relapsed or refractory acute myeloid leukemia (AML). Enrolled patients must be HLA-A\*02:01+ and positive for the NPM1 mutation which produces the alternative amino acid sequence CLAVEEVSL (Type A, D, G or H). The study is an adaptive dose escalation design with up to 3 cohorts to evaluate single doses of BSB-2002, employing the 3+3 design.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
19
Patients will receive BSB-2002 as a single IV infusion at day 1 following the lymphodepletion regime.
Patients will receive BSB-2002 as a single IV infusion at day 1 following the lymphodepletion regime.
Washington University at St Louis
St Louis, Missouri, United States
RECRUITINGNumber of participants with dose-limiting toxicity, adverse events (AEs) and serious AEs (SAEs)
Incidence of dose-limiting toxicity, frequency and severity of adverse events (AEs) and serious AEs (SAEs)
Time frame: 365 days
Number of Patients with Relapse
Presence of malignant cells in marrow (\>5%), peripheral blood (\>1%), or extramedullary sites by histopathology after achievement of CR, CRh or CRi any time after study treatment.
Time frame: 365 days
Cellular kinetics of BSB-2002 in peripheral blood
Quantitation of BSB-2002 (copies per μL of genomic DNA)
Time frame: 365 days
Overall survival
Defined as the time from treatment to death due to any cause
Time frame: Through 365 days
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