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RECRUITING
NCT06704152
PHASE1/PHASE2

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

Sponsor: BlueSphere Bio, Inc

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to test BSB-1001 which is a new type of cellular therapy to treat blood cancers (AML, ALL and MDS). It will evaluate the safety of BSB-1001 and also determine whether it works to prevent relapse of your cancer.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

38

Start Date

2025-02-04

Completion Date

2029-03

Last Updated

2025-09-18

Healthy Volunteers

No

Interventions

DRUG

SOC + BSB-1001 Dose Escalation Cohort

Patients will receive BSB-1001 a single intravenous (IV) infusion on day 0 following the infusion of the CD34-allo hematopoietic stem cell transplant (HCT).

DRUG

SOC+BSB-1001 Expansion Dose

Patients will receive BSB-1001 a single intravenous (IV) infusion on day 0 following the infusion of the CD34-allo hematopoietic cell transplant (HCT).

Locations (6)

City of Hope National Medical Center

Duarte, California, United States

Moffitt Cancer Center

Tampa, Florida, United States

University of Michigan

Ann Arbor, Michigan, United States

University of Minnesota

Minneapolis, Minnesota, United States

Washington University at St Louis

St Louis, Missouri, United States

The Ohio State University

Columbus, Ohio, United States