StudyFinder
MT2024-33 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
Recruiting
This study is designed to determine whether BSB-1001 - a product made of genetically modified cells - is safe and possibly effective when given to patients with Acute Myelogenous Leukemia (AML), Acute Lymphocytic Leukemia (ALL), or Myelodysplastic Syndrome (MDS) who are also receiving a stem cell transplant with a matched donor.
Male or Female
18 years and over
Inclusion Criteria:
• ages 18 - 70 years inclusive, having a alloHCT.
• any of the following high-risk hematologic malignancies: • AML which has been treated with at least two lines of therapy, and refractory or relapsed • ALL • MDS after at least one line of therapy, which includes hypomethylating agent(s) and venetoclax and must be high or very high risk • AML patients who have been treated with at least two lines of therapy, and refractory or relapsed
• suitable for one of the approved conditioning regimens as defined in the protocol
• must have an identified donor that is HA 1-negative with 10/10 matched related donor or 12/12 matched unrelated donor
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
Exclusion Criteria:
• weight \> 100 kg. (220 lbs)
• prior history of allogeneic or autologous stem cell transplantation
• 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.
• recent treatment with other investigational agents
• history of treatment with checkpoint inhibitor therapy within 3 months of transplantation
• women who are pregnant or breast feeding
• uncontrolled bacterial, viral, or fungal infections
• CNS involvement that hasn't responded to intrathecal chemotherapy and/or standard cranial- spinal radiation.
• unable to work; able to live at home and care for most personal needs; requires occasional assistance, but is able to care for most personal needs or better performance
Drug: SOC + BSB-1001 Dose Escalation Cohort, Drug: SOC+BSB-1001 Expansion Dose
Cancer
ALL, AML, MDS, stem cell transplant, Clinics and Surgery Center (CSC), Adult Recurrent
Mark Juckett - juck0001@umn.edu
Mark Juckett
PHASE1
STUDY00023637
See this study on ClinicalTrials.gov