Actively Recruiting
BSB-1001 in Patients Undergoing HLA-Matched Allogenic Hematopoietic Stem Cell Transplant for AML, ALL or MDS
Led by BlueSphere Bio, Inc · Updated on 2025-09-18
38
Participants Needed
6
Research Sites
212 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
BSB-1001 in Patients Undergoing HLA-Matched Allogenic Hematopoietic Stem Cell Transplant for AML, ALL or MDS
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female patients aged 18 to 70 years undergoing allogeneic hematopoietic stem cell transplantation (alloHCT)
- Diagnosed with high-risk AML treated with at least two lines of therapy, including refractory or relapsed disease, or MRD positive, or persistent disease-defining cytogenetic abnormality
- Diagnosed with ALL with 5% to 25% abnormal lymphoblasts in bone marrow, or persistent disease-defining cytogenetic abnormality, or MRD positive
- Diagnosed with high or very high risk MDS after at least one line of therapy, including hypomethylating agents, or with monosomy, complex karyotype, or TP53 mutation
- HLA-A*02:01 and HA-1 positive (H/H or H/R)
- Suitable for approved conditioning regimens
- Have an identified 10/10 matched related or unrelated donor who is HA-1 negative
You will not qualify if you...
- Weight over 100 kg
- Prior allogeneic stem cell transplantation
- Prior autologous stem cell transplantation within 1 year before planned BSB-1001 dosing
- Previous CAR-T therapy within 2 years before screening, except autologous CAR-T for ALL
- Treatment with other investigational agents within 5 half-lives before planned BSB-1001 dosing
- Treatment with checkpoint inhibitor therapy within 3 months before transplantation
- Other malignancy with life expectancy less than 1 year
- Pregnant or breastfeeding women
- Uncontrolled bacterial, viral, or fungal infections at enrollment
- Past or current viral infections as defined by the protocol
- CNS involvement refractory to intrathecal chemotherapy or cranial-spinal radiation
- Karnofsky Performance Score below 60%
- Inadequate organ function as defined in the protocol
AI-Screening
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Trial Site Locations
Total: 6 locations
1
City of Hope National Medical Center
Duarte, California, United States, 91010
Actively Recruiting
2
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
3
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
4
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
5
Washington University at St Louis
St Louis, Missouri, United States, 63110
Actively Recruiting
6
The Ohio State University
Columbus, Ohio, United States, 43210
Actively Recruiting
Research Team
M
Medical Director: Nawazish Khan, MD, BlueSphere Bio
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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