BSB-1001 in Patients Undergoing HLA-Matched Allogenic Hematopoietic Stem Cell Transplant for AML, ALL or MDS
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorBlueSphere Bio, Inc
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male or female patients, ages 18 - 70 years inclusive, undergoing alloHCT.
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
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 mutation.
Disqualifiers
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 CAR-T product.
Trial design
Design model
Sequential
Treatments tested in this trial
SOC + BSB-1001 Dose Escalation Cohort
DrugPatients will receive BSB-1001 a single intravenous (IV) infusion on day 0 following the infusion of the CD34-allo hematopoietic stem cell transplant (HCT).
SOC+BSB-1001 Expansion Dose
DrugPatients will receive BSB-1001 a single intravenous (IV) infusion on day 0 following the infusion of the CD34-allo hematopoietic cell transplant (HCT).
Treatment groups
38 Participants
are divided into 2 treatment groupsGroup A: Dose Escalation CohortsExperimental treatment 1 intervention
Group B: BSB-1001 Expansion DoseExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of participants with treatment-emergent adverse events (TEAEs), including SAEs, GVHD and dose-limiting toxicities
Incidence of TEAEs (per Common Terminology Criteria for Adverse Events \[CTCAE\])
Time frame
365 days2
Cellular kinetics of BSB-1001 in peripheral blood
Quantitation of BSB-1001 (copies per μL of genomic DNA)
Time frame
365 daysSecondary outcomes
1
Number of patients with relapse
Presence of malignant cells in marrow (\>5%), peripheral blood (\>1%), or extramedullary sites by histopathology after achievement of CR, CRh or CRi at any time after HSCT
Time frame
Through 365 days post HSCT2
Incidence of Grades II-IV acute GVHD
Acute GVHD will be graded and assessed for response based on the MAGIC consortium scoring system
Time frame
Through 100 days post HSCT3
Incidence of Grades III-IV acute GVHD
Acute GVHD will be graded and assessed for response based on the MAGIC consortium scoring system
Time frame
Through 100 days post HSCT4
Time to neutrophil engraftment
Time to the first of 3 consecutive days of absolute neutrophil counts ≥ 500/µL
Time frame
Through 365 days post HSCTSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov