Study on BSB-1001 for Patients Undergoing HLA-Matched Stem Cell Transplant for Blood Cancers
Sponsor: BlueSphere Bio, Inc
ClinicalTrials ID:NCT06704152
This clinical trial is testing a new cellular therapy called BSB-1001 to see if it can safely prevent the return of certain blood cancers, such as AML, ALL, and MDS, in patients receiving a stem cell transplant from a matched donor.
Patient Parameters
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Program Overview
The purpose of this study is to evaluate the safety and effectiveness of a new treatment called BSB-1001, which is a type of cellular therapy. This treatment is being tested in patients with blood cancers like AML, ALL, and MDS who are undergoing a stem cell transplant from a donor with a matching HLA type. The study aims to see if BSB-1001 can help prevent the cancer from coming back after the transplant.
Description
This study is the first to test BSB-1001 in humans and involves multiple centers. It is open-label, meaning both the researchers and participants know what treatment is being given. The study is designed to find the right dose of BSB-1001, which is a T cell product modified to target specific cancer markers. Patients eligible for this study have blood cancers like AML, ALL, or MDS and are at high risk of their cancer returning after a stem cell transplant.
Participants will receive a stem cell transplant from a donor who is a match for their HLA type but does not have the HA-1 marker. After preparing the body with chemotherapy and radiation, patients will receive the BSB-1001 treatment on the same day as the transplant. The study will test different doses of BSB-1001 to find the safest and most effective amount. If a promising dose is found, more patients may be treated at that dose level to gather additional information.
The study will include 3 to 6 patients in each dose group, and participants will be monitored throughout the study to assess the treatment's safety and effectiveness. If a dose is found to be safe and effective, the study may expand to include more patients with AML at that dose level.
Eligibility Criteria
Inclusion Criteria
- Men and women aged 18 to 70 undergoing a stem cell transplant.
- Diagnosed with high-risk blood cancers such as:
- AML treated with at least two therapies, with specific conditions like persistent cancer cells or genetic markers.
- ALL with a certain percentage of abnormal cells or genetic markers.
- MDS treated with specific drugs and classified as high risk.
- Must have specific genetic markers (HLA-A*02:01 and HA-1 positive).
- Suitable for approved chemotherapy and radiation regimens.
- Must have a donor who is a 10/10 match and HA-1 negative.
Exclusion Criteria
- Weigh more than 100 kg.
- Have had a previous allogeneic stem cell transplant.
- Have had an autologous stem cell transplant within the past year.
- Have received CAR-T cell therapy within the past two years, except for certain ALL patients.
- Have taken other experimental treatments recently.
- Have used checkpoint inhibitors within three months of the transplant.
- Have another cancer with a life expectancy of less than one year.
- Are pregnant or breastfeeding.
- Have uncontrolled infections.
- Have certain viral infections.
- Have cancer in the central nervous system that is not responding to treatment.
- Have a performance score below 60%.
- Have poor organ function.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| City of Hope National Medical Center | 91010 | Duarte | California |
| Moffitt Cancer Center | 33612 | Tampa | Florida |
| University of Michigan | 48109 | Ann Arbor | Michigan |
| University of Minnesota | 55455 | Minneapolis | Minnesota |
| Washington University at St Louis | 63110 | St Louis | Missouri |
| The Ohio State University | 43210 | Columbus | Ohio |
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