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BSB-1001 for AML, ALL, or MDS after Stem Cell Transplant

This study is testing a new cell therapy called BSB-1001 for people aged 18 to 70 who have acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), or myelodysplastic syndromes (MDS) and are undergoing an HLA-matched allogeneic hematopoietic stem cell transplant (a transplant using stem cells from a donor). The goal is to see how safe BSB-1001 is and if it can help prevent your cancer from coming back. You would receive BSB-1001 as a single infusion on the same day as your stem cell transplant. To join, you must have specific genetic markers (HLA-A*02:01 and HA-1 positive) and your donor must be HA-1 negative. The study will look at side effects and how BSB-1001 moves through your body.

Study design
This is a multicenter, open-label study with an adaptive dose escalation design, meaning the dose of BSB-1001 may change as the study progresses. It plans to enroll 38 participants.
What's involved
You would receive a single intravenous (IV) infusion of BSB-1001 on day 0, following your stem cell transplant. You will be followed for 365 days after treatment.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 365 days after receiving BSB-1001.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06704152

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

Recruiting
PHASE1Ages 18–70InterventionalTreatment
BlueSphere Bio, Inc
~38 participants
Updated 2025-09-18 on ClinicalTrials.gov
What's tested:SOC + BSB-1001 Dose Escalation CohortSOC+BSB-1001 Expansion Dose

At a glance

Recruiting sites
6 of 6 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants with treatment-emergent adverse events (TEAEs), including SAEs, GVHD and dose-limiting toxicities
Measured over 365 days
+1 more outcome measured

Conditions

AML, Adult Recurrent
ALL, Recurrent, Adult
MDS

Explore related trials

Acute Lymphoblastic LeukemiaAcute Myeloid LeukemiaHematologic NeoplasmMyelodysplastic SyndromeHLA Class I Histocompatibility Antigen, A-0201 Alpha ChainKERATIN 31, TYPE I

Where it's being run

6 sites across 6 states
California1
Florida1
Michigan1
Minnesota1
Missouri1
Ohio1

Who to contact

Medical Director: Nawazish Khan, MD, BlueSphere Bio
[email protected]
252-347-4938
Email the study team

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What this trial measures

  • Number of participants with treatment-emergent adverse events (TEAEs), including SAEs, GVHD and dose-limiting toxicities365 days

    Incidence of TEAEs (per Common Terminology Criteria for Adverse Events \[CTCAE\])

  • Cellular kinetics of BSB-1001 in peripheral blood365 days

    Quantitation of BSB-1001 (copies per μL of genomic DNA)