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
Qualifiers
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
Treatments tested in this trial
- SOC + BSB-1001 Dose Escalation Cohort
- SOC+BSB-1001 Expansion Dose
Treatment groups
38 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov