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

Launched by BLUESPHERE BIO, INC · Nov 22, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called BSB-1001 for patients with certain types of blood cancers, specifically Acute Myeloid Leukemia (AML), Acute Lymphoblastic Leukemia (ALL), or Myelodysplastic Syndromes (MDS). The main goal of the trial is to see if BSB-1001 is safe and whether it can help prevent the cancer from coming back after a stem cell transplant. The researchers are looking for participants aged 18 to 70 who are undergoing a specific type of stem cell transplant known as HLA-matched allogeneic hematopoietic stem cell transplant.

To be eligible for this trial, patients need to have high-risk blood cancers that have already been treated, and they must have a suitable donor for the transplant. Participants can expect to receive the new treatment alongside standard care and will be monitored closely for any side effects or changes in their condition. It's important to know that certain health issues or previous treatments may exclude someone from participating, so discussing eligibility with a healthcare provider is crucial.

Gender

ALL

Eligibility criteria

• Inclusion 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
• Exclusion Criteria:
• • 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.