BSB-1001 in Patients Undergoing HLA-Matched Allogenic Hematopoietic Stem Cell Transplant for AML, ALL or MDS

Eligibility Criteria

• 1. Male or female patients, ages 18 - 70 years inclusive, undergoing alloHCT.
• 2. Any Any of the following high-risk hematologic malignancies:
• 1. AML diagnosed which has been treated with at least two lines of therapy, and refractory or relapsed (CR, CRh or CRi,), including myeloblasts up to 25% OR MRD positive OR persistent disease-defining cytogenetic abnormality OR MRD-negative, but with high-risk disease
• 2. ALL which has been with abnormal lymphoblasts ≥5% and up to 25% in bone marrow OR persistent disease-defining cytogenetic abnormality or MRD positive
• 3. MDS after at least one line of therapy, which includes hypomethylating agent(s) and venetoclax and must be high or very high risk by Revised International Prognostic Scoring System (IPSS-R), monosomy, or complex karyotype or TP53 mutation.
• 4. In the expansion phase AML patients diagnosed which has been treated with at least two lines of therapy, and refractory or relapsed (CR, CRh or CRi,), including myeloblasts up to 25% OR MRD positive OR persistent disease-defining cytogenetic abnormality OR MRD-negative, but with high- risk disease
• 3. HLA-A\*02:01 AND HA-1 positive (either H/H or H/R).
• 4. Suitable for one of the approved conditioning regimens as defined in the protocol.
• 5. Patient must have an identified donor that is HA 1-negative with 10/10 matched related donor or 12/12 matched unrelated donor
• 1. Weight \> 100 kg.
• 2. Prior history of allogeneic or autologous stem cell transplantation.
• 3. Previous genetically engineered chimeric antigen receptor T Cell therapy (CAR-T), approved or investigational, within 2 years of screening, with the exception of patients with ALL previously treated with an autologous CAR-T product.
• 4. Treatment with other investigational agents within 5 half-lives of the planned dosing of BSB-1001 (day 0).
• 5. History of treatment with checkpoint inhibitor therapy within 3 months of t transplantation.
• 6. Other malignancy with life expectancy \< 1year.
• 7. Pregnant or lactating women.
• 8. Uncontrolled bacterial, viral, or fungal infections at time of enrollment.
• 9. Past or current viral infections as defined in the protocol.
• 10. CNS involvement refractory to intrathecal chemotherapy and/or standard cranial- spinal radiation.
• 11. Karnofsky Performance Score \< 60%.
• 12. Inadequate organ function as defined in protocol.