Phase 12a Study of BSB-1001, a Modified T Cell Therapy, in Adults Undergoing HLA-Matched Stem Cell Transplant for Blood Cancers AML, ALL, or MDS

What this Trial Is About

Researchers are evaluating BSB-1001, a new type of cellular therapy, in patients with blood cancers such as AML, ALL, and MDS who are undergoing an HLA-matched allogenic hematopoietic stem cell transplant alloHSCT. This first-in-human study aims to assess the safety of BSB-1001 and determine if it can help prevent cancer relapse. The trial focuses on patients at high risk of relapse after transplant and involves a dose-finding design with multiple cohorts. Participants will receive one of several doses of BSB-1001, which is a TCR-modified T cell product targeting the HA-1 minor histocompatibility antigen. The treatment is given as a single intravenous infusion on the day of stem cell transplant day 0, following a myeloablative conditioning regimen and CD34-selected alloHSCT. The study includes dose escalation cohorts to find the maximum tolerated dose, and an optional expansion phase enrolling additional AML patients at the recommended dose. During the study, participants will be closely monitored for treatment-emergent adverse events, graft-versus-host disease GVHD, and dose-limiting toxicities for up to 365 days. Researchers will also measure cell kinetics of BSB-1001 in the blood and track outcomes such as relapse, survival, engraftment times, infections, and GVHD incidence. Follow-up assessments will include clinical evaluations and laboratory tests to ensure safety and effectiveness over the study period.

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