BSB-1001 in Patients Undergoing HLA-Matched Allogenic Hematopoietic Stem Cell Transplant for AML, ALL or MDS
Recruiting
Phase 1Phase 2Interventional Study
AML, Adult RecurrentALL, Recurrent, AdultMDS
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 70
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
38 (estimated)
Sponsor
BlueSphere Bio, Inc · Industry
Who this trial is looking for
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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.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Male or female patients, ages 18 - 70 years inclusive, undergoing alloHCT.
2. Any of the following high-risk hematologic malignancies:
1. AML diagnosed which has been treated with at least two lines of therapy\* Refractory or relapsed (CR, CRh or CRi,), including myelobla…
Inclusion Criteria:
1. Male or female patients, ages 18 - 70 years inclusive, undergoing alloHCT.
2. Any of the following high-risk hematologic malignancies:
1. 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 OR MRD-negative, but with high-risk disease For patients in remission meeting criteria a, consolidation regimens would be considered another line of therapy of eligibility purposes
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 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 or unrelated donor
Exclusion Criteria:
1. Weight \> 100 kg.
2. Prior history of allogeneic stem cell transplantation
3. Prior history of autologous stem cell transplantation within 1 year prior to the planned dosing of BSB-1001 (day 0)
4. 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.
5. Treatment with other investigational agents within 5 half-lives of the planned dosing of BSB-1001 (day 0).
6. History of treatment with checkpoint inhibitor therapy within 3 months of transplantation.
7. Other malignancy with life expectancy \< 1year.
8. Pregnant or lactating women.
9. Uncontrolled bacterial, viral, or fungal infections at time of enrollment.
10. Past or current viral infections as defined in the protocol.
11. 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.
Contacts
Medical Director: Nawazish Khan, MD, BlueSphere Bio
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