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A Phase 1/2a Multicenter Ascending Dose Study to Evaluate the Safety of HA-1 Minor Histocompatibility Antigen-Reactive TCR-Modified T Cells (BSB-1001) in Patients Undergoing HLA-Matched Allogenic Hematopoietic Stem Cell Transplant for AML, ALL or MDS

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Trial Profile

A Phase 1/2a Multicenter Ascending Dose Study to Evaluate the Safety of HA-1 Minor Histocompatibility Antigen-Reactive TCR-Modified T Cells (BSB-1001) in Patients Undergoing HLA-Matched Allogenic Hematopoietic Stem Cell Transplant for AML, ALL or MDS

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 19 Mar 2025

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At a glance

  • Drugs BSB 1001 (Primary) ; Busulfan; Fludarabine; Melphalan; Thiotepa
  • Indications Acute myeloid leukaemia; Myelodysplastic syndromes; Precursor cell lymphoblastic leukaemia-lymphoma
  • Focus Adverse reactions; First in man; Pharmacodynamics
  • Sponsors BlueSphere Bio

    • Most Recent Events

    • 15 Jan 2025 Planned initiation date (estimated date for recruitment of the first subject) changed from 1 Dec 2024 to 1 Feb 2025.
    • 15 Jan 2025 Status changed from not yet recruiting to recruiting.
    • 25 Nov 2024 Status changed from planning to not yet recruiting.

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