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.
Male or female patients, ages 18 years or older,
AML diagnosed per ELN criteria1 which has been treated with at least two lines of therapy,
which is relapsed (after previously complete remission, CR, CRh or CRi), or
refractory (failed to achieve complete remission) to the last treatment*, *Primary refractory patients should have received at least two cycles of induction treatment
Leukemic blast count of >20,000/μl. If the blast count can be maintained below the threshold with hydroxyurea, the patient would be eligible.
Patients with extramedullary only AML.
Patients that are candidates for hematopoietic stem cell transplant.
Patients that are eligible to receive an approved targeted therapy.
Sequential
SOC+ BSB-2002
DrugPatients will receive BSB-2002 as a single IV infusion at day 1 following the lymphodepletion regime.
SOC+BSB-2002
DrugPatients will receive BSB-2002 as a single IV infusion at day 1 following the lymphodepletion regime.
Number 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)
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.
Cellular kinetics of BSB-2002 in peripheral blood
Quantitation of BSB-2002 (copies per μL of genomic DNA)
Overall survival
Defined as the time from treatment to death due to any cause
Malignant Cell presence detected by Molecular MRD Methods
Presence of malignant cells in the marrow, peripheral blood, or extramedullary sites detectable only by molecular methods
Cellular kinetics of serum cytokines and biomarkers
Evaluation of inflammatory cytokines and other potential biomarkers
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