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OncoMatch/Clinical Trials/NCT06704152

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

Is NCT06704152 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including SOC + BSB-1001 Dose Escalation Cohort and SOC+BSB-1001 Expansion Dose for aml, adult recurrent.

Phase 1/2RecruitingBlueSphere Bio, IncNCT06704152Data as of May 2026

Treatment: SOC + BSB-1001 Dose Escalation Cohort · SOC+BSB-1001 Expansion DoseThe 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.

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Extracted eligibility criteria

Cancer type

Acute Myeloid Leukemia

Acute Lymphoblastic Leukemia

Myelodysplastic Syndrome

Biomarker criteria

Required: HLA-A A*02:01 positive

HLA-A*02:01

Required: HA-1 positive (either H/H or H/R)

HA-1 positive (either H/H or H/R)

Allowed: TP53 mutation

TP53 mutation

Prior therapy

Must have received:

AML diagnosed which has been treated with at least two lines of therapy

Must have received:

MDS after at least one line of therapy, which includes hypomethylating agent(s)

Cannot have received: allogeneic stem cell transplantation

Prior history of allogeneic stem cell transplantation

Cannot have received: autologous stem cell transplantation

Exception: within 1 year prior to the planned dosing of BSB-1001 (day 0)

Prior history of autologous stem cell transplantation within 1 year prior to the planned dosing of BSB-1001 (day 0)

Cannot have received: CAR-T cell therapy

Exception: patients with ALL previously treated with an autologous CAR-T product

Previous genetically engineered chimeric antigen receptor T Cell therapy (CAR-T), approved or investigational, within 2 years of screening, with the exception of patients with ALL previously treated with an autologous CAR-T product

Cannot have received: investigational agent

Exception: within 5 half-lives of the planned dosing of BSB-1001 (day 0)

Treatment with other investigational agents within 5 half-lives of the planned dosing of BSB-1001 (day 0)

Cannot have received: checkpoint inhibitor

Exception: within 3 months of transplantation

History of treatment with checkpoint inhibitor therapy within 3 months of transplantation

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • City of Hope National Medical Center · Duarte, California
  • Moffitt Cancer Center · Tampa, Florida
  • University of Michigan · Ann Arbor, Michigan
  • University of Minnesota · Minneapolis, Minnesota
  • Washington University at St Louis · St Louis, Missouri

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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