A Phase 1 Multicenter Dose Finding Study to Evaluate the Safety of BSB-2002 in Relapsed or Refractory Acute Myeloid Leukemia (AML) Patients With NPM1 Mutation
BlueSphere Bio, Inc
Summary
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.
Description
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 B…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Male or female patients, ages 18 years or older, 2. AML diagnosed per ELN criteria1 which has been treated with at least two lines of therapy, 1. which is relapsed (after previously complete remission, CR, CRh or CRi), or 2. refractory (failed to achieve complete remission) to the last treatment\*, \*Primary refractory patients should have received at least two cycles of induction treatment 3. Patients who are MRD positive by NGS for NPM1 after being MRD negative following the last treatment 4. HLA-A\*02:01, 5. Positive for NPM1 mutation type A, D, G or H (see Ap…
Interventions
- DrugSOC+ BSB-2002
Patients will receive BSB-2002 as a single IV infusion at day 1 following the lymphodepletion regime.
- DrugSOC+BSB-2002
Patients will receive BSB-2002 as a single IV infusion at day 1 following the lymphodepletion regime.
Location
- Washington University at St LouisSt Louis, Missouri