RECRUITING

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

Conditions

AML, Adult Recurrent ALL, Recurrent, Adult MDS TCR, T-cell therapy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase 1/2a Multicenter Ascending Dose Study to Evaluate the Safety of HA-1 Minor Histocompatibility Antigen-Reactive TCR-Modified T Cells (BSB-1001) in Patients Undergoing HLA-Matched Allogenic Hematopoietic Stem Cell Transplant for AML, ALL or MDS

Quick Facts

Study Start:2025-02

Study Completion:2029-03

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06704152

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Male or female patients, ages 18 - 70 years inclusive, undergoing alloHCT. 2. Any Any of the following high-risk hematologic malignancies: 1. AML diagnosed which has been treated with at least two lines of therapy, and refractory or relapsed (CR, CRh or CRi,), including myeloblasts up to 25% OR MRD positive OR persistent disease-defining cytogenetic abnormality OR MRD-negative, but with high-risk disease 2. ALL which has been with abnormal lymphoblasts ≥5% and up to 25% in bone marrow OR persistent disease-defining cytogenetic abnormality or MRD positive 3. MDS after at least one line of therapy, which includes hypomethylating agent(s) and venetoclax and must be high or very high risk by Revised International Prognostic Scoring System (IPSS-R), monosomy, or complex karyotype or TP53 mutation. 4. In the expansion phase AML patients diagnosed which has been treated with at least two lines of therapy, and refractory or relapsed (CR, CRh or CRi,), including myeloblasts up to 25% OR MRD positive OR persistent disease-defining cytogenetic abnormality OR MRD-negative, but with high- risk disease 3. HLA-A\*02:01 AND HA-1 positive (either H/H or H/R). 4. Suitable for one of the approved conditioning regimens as defined in the protocol. 5. Patient must have an identified donor that is HA 1-negative with 10/10 matched related donor or 12/12 matched unrelated donor	1. Weight \> 100 kg. 2. Prior history of allogeneic or autologous stem cell transplantation. 3. 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. 4. Treatment with other investigational agents within 5 half-lives of the planned dosing of BSB-1001 (day 0). 5. History of treatment with checkpoint inhibitor therapy within 3 months of t transplantation. 6. Other malignancy with life expectancy \< 1year. 7. Pregnant or lactating women. 8. Uncontrolled bacterial, viral, or fungal infections at time of enrollment. 9. Past or current viral infections as defined in the protocol. 10. CNS involvement refractory to intrathecal chemotherapy and/or standard cranial- spinal radiation. 11. Karnofsky Performance Score \< 60%. 12. Inadequate organ function as defined in protocol.

Inclusion Criteria

Exclusion Criteria

1. Male or female patients, ages 18 - 70 years inclusive, undergoing alloHCT.
2. Any Any of the following high-risk hematologic malignancies:
1. AML diagnosed which has been treated with at least two lines of therapy, and refractory or relapsed (CR, CRh or CRi,), including myeloblasts up to 25% OR MRD positive OR persistent disease-defining cytogenetic abnormality OR MRD-negative, but with high-risk disease
2. ALL which has been with abnormal lymphoblasts ≥5% and up to 25% in bone marrow OR persistent disease-defining cytogenetic abnormality or MRD positive
3. MDS after at least one line of therapy, which includes hypomethylating agent(s) and venetoclax and must be high or very high risk by Revised International Prognostic Scoring System (IPSS-R), monosomy, or complex karyotype or TP53 mutation.
4. In the expansion phase AML patients diagnosed which has been treated with at least two lines of therapy, and refractory or relapsed (CR, CRh or CRi,), including myeloblasts up to 25% OR MRD positive OR persistent disease-defining cytogenetic abnormality OR MRD-negative, but with high- risk disease
3. HLA-A\*02:01 AND HA-1 positive (either H/H or H/R).
4. Suitable for one of the approved conditioning regimens as defined in the protocol.
5. Patient must have an identified donor that is HA 1-negative with 10/10 matched related donor or 12/12 matched unrelated donor

1. Weight \> 100 kg.
2. Prior history of allogeneic or autologous stem cell transplantation.
3. 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.
4. Treatment with other investigational agents within 5 half-lives of the planned dosing of BSB-1001 (day 0).
5. History of treatment with checkpoint inhibitor therapy within 3 months of t transplantation.
6. Other malignancy with life expectancy \< 1year.
7. Pregnant or lactating women.
8. Uncontrolled bacterial, viral, or fungal infections at time of enrollment.
9. Past or current viral infections as defined in the protocol.
10. CNS involvement refractory to intrathecal chemotherapy and/or standard cranial- spinal radiation.
11. Karnofsky Performance Score \< 60%.
12. Inadequate organ function as defined in protocol.

Contacts and Locations

Study Contact

Study Director: Erkut Bahceci, MD, BlueSphere Bio

CONTACT

224-488-0962

eBahceci@bluespherebio.com

Study Locations (Sites)

Washington University at St Louis

St. Louis, Missouri, 63110

United States

Collaborators and Investigators

Sponsor: BlueSphere Bio, Inc

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02

Study Completion Date2029-03

Study Record Updates

Study Start Date2025-02

Study Completion Date2029-03

Terms related to this study

Keywords Provided by Researchers

TCR, T-cell therapy

Additional Relevant MeSH Terms

AML, Adult Recurrent
ALL, Recurrent, Adult
MDS