RecruitingPhase 1Phase 2NCT06704152

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

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

Sponsor

BlueSphere Bio, Inc

Enrollment

38 participants

Start Date

Feb 4, 2025

Study Type

INTERVENTIONAL

Conditions

MDS AML, Adult Recurrent ALL, Recurrent, Adult

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.

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new treatment called BSB-1001 — which is designed to direct donated immune cells (from a stem cell transplant) to target and destroy residual cancer cells — in people with high-risk leukemia or a bone marrow disorder (MDS) who are undergoing a matched stem cell transplant. **You may be eligible if...** - You are between 18 and 70 years old and are undergoing an HLA-matched allogeneic (donor) stem cell transplant - You have high-risk acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), or myelodysplastic syndrome (MDS) that has been treated with at least one prior therapy - You carry specific genetic markers (HLA-A*02:01 and HA-1 positive) - You have an identified donor who is HA-1 negative and matched at 10 of 10 tissue type markers **You may NOT be eligible if...** - You do not have the required genetic markers - You do not have a suitable matched donor - Your cancer type or stage does not meet the specific criteria for the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSOC + 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).

DRUGSOC+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).