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New treatment option for AML, Adult Recurrent
Official title BSB-1001 in Patients Undergoing HLA-Matched Allogenic Hematopoietic Stem Cell Transplant for AML, ALL or MDS
ClinicalTrials.gov ID: NCT06704152
What this study is testing
What is SOC + BSB-1001 Dose Escalation Cohort?
SOC + BSB-1001 Dose Escalation Cohort is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for aml, adult recurrent.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Male or female patients, ages 18 - 70 years inclusive, undergoing alloHCT.
- Any of the following high-risk hematologic malignancies:
- AML diagnosed which has been treated with at least two lines of therapy\ Refractory or relapsed (CR, CRh or CRi,), including myeloblasts up to 25% OR...
- ALL which has been with abnormal lymphoblasts ≥5% and up to 25% in bone marrow OR persistent disease-defining cytogenetic abnormality or MRD positive
- MDS after at least one line of therapy, which includes hypomethylating agent(s) and must be high or very high risk by Revised International...
You likely can't join if
- Weight \> 100 kg.
- Prior history of allogeneic stem cell transplantation
- Prior history of autologous stem cell transplantation within 1 year prior to the planned dosing of BSB-1001 (day 0)
- Previous genetically engineered chimeric antigen receptor T Cell therapy (CAR-T), approved or investigational, within 2 years of screening, with the...
- Treatment with other investigational agents within 5 half-lives of the planned dosing of BSB-1001 (day 0).
- History of treatment with checkpoint inhibitor therapy within 3 months of transplantation.
See the full eligibility criteria
- Male or female patients, ages 18 - 70 years inclusive, undergoing alloHCT.
- Any of the following high-risk hematologic malignancies:
- AML diagnosed which has been treated with at least two lines of therapy\ Refractory or relapsed (CR, CRh or CRi,), including myeloblasts up to 25% OR MRD positive OR persistent disease-defining cytogenetic abnormality...
- ALL which has been with abnormal lymphoblasts ≥5% and up to 25% in bone marrow OR persistent disease-defining cytogenetic abnormality or MRD positive
- MDS after at least one line of therapy, which includes hypomethylating agent(s) and must be high or very high risk by Revised International Prognostic Scoring System (IPSS-R), monosomy, or complex karyotype or TP53...
- 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...
- HLA-A\ 02:01 AND HA-1 positive (either H/H or H/R).
- Suitable for one of the approved conditioning regimens as defined in the protocol.
- Patient must have an identified donor that is HA 1-negative with 10/10 matched related or unrelated donor
- Weight \> 100 kg.
- Prior history of allogeneic stem cell transplantation
- Prior history of autologous stem cell transplantation within 1 year prior to the planned dosing of BSB-1001 (day 0)
- 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...
- Treatment with other investigational agents within 5 half-lives of the planned dosing of BSB-1001 (day 0).
- History of treatment with checkpoint inhibitor therapy within 3 months of transplantation.
- Other malignancy with life expectancy \< 1year.
- Pregnant or lactating women.
- Uncontrolled bacterial, viral, or fungal infections at time of enrollment.
- Past or current viral infections as defined in the protocol.
- CNS involvement refractory to intrathecal chemotherapy and/or standard cranial- spinal radiation. 12 Karnofsky Performance Score \< 60%. 13\. Inadequate organ function as defined in protocol.
The study team makes the final eligibility decision.
Where it's taking place
- Duarte, California, United States
- Tampa, Florida, United States
- Ann Arbor, Michigan, United States
- Minneapolis, Minnesota, United States
- St Louis, Missouri, United States
- Columbus, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Duarte, California, United States; Tampa, Florida, United States; Ann Arbor, Michigan, United States; Minneapolis, Minnesota, United States; St Louis, Missouri, United States; Columbus, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.