Phase I, First in Human, Open Label Study to Evaluate Safety and Tolerability of TRX103 Cells in Subjects With Hematological Malignancies Undergoing HLA-mismatched Related or Unrelated Hematopoietic Stem Cell Transplantation (HSCT)
The purpose of this Phase 1, first in human open-label study is to assess the safety and tolerability of TRX-103 in patients with hematological malignancies undergoing HLA-mismatched related or unrelated hematopoietic stem cell transplantation (HSCT). It is anticipated that up to 36 Subjects will be enrolled during a 18-24 month enrollment period. TRX-103 will be infused one time post HSCT.
• Subjects with one of the following hematologic malignancies: Acute Lymphoblastic Leukemia (B- or T-ALL), Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS), or Chronic myelomonocytic leukemia (CMML)
• Males and Females Age ≥ 18 years.
• Weight of ≥ 35 Kg.
• Karnofsky performance status ≥ 70 %.
• Available mismatched related (haploidentical) or unrelated donors for peripheral blood stem cell (PBSC) donation.
• Subjects must otherwise fulfill institutional criteria for eligibility to undergo allogeneic stem cell transplantation.
• Absence of uncontrolled bacterial, viral or fungal infection at time of enrollment.
• Have adequate organ function.
• Subjects \> 65-year-old receiving MAC conditioning will only be eligible if they have a HSCT-comorbidity index score \< 5.
⁃ Subjects must be able to understand and sign informed consent and be willing and able to complete all specified procedures and visits.