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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 (Jun 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 Jun 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

Treatments studied

Other

SOC + BSB-1001 Dose Escalation CohortSOC+BSB-1001 Expansion Dose

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

Demographics

Ages ≤ 70

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 →

Frequently asked questions

Is NCT06704152 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior allogeneic stem cell transplantation, autologous stem cell transplantation, CAR-T cell therapy disqualifies patients from enrollment.

Does this trial require HLA-A?

Yes, HLA-A A*02:01 positive is a required biomarker for enrollment.

Does this trial require HA-1?

Yes, HA-1 positive (either H/H or H/R) is a required biomarker for enrollment.

Is there an age limit?

Yes. Patients must be 70 years or younger.

Could you qualify for this trial?

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

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