Tr1X, Inc.
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.
Inclusion Criteria: 1. 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) 2. Males and Females Age ≥ 18 years. 3. Weight of ≥ 35 Kg. 4. Karnofsky performance status ≥ 70 %. 5. Available mismatched related (haploidentical) or unrelated donors for peripheral blood stem cell (PBSC) donation. 6. Subjects must otherwise fulfill institutional criteria for eligibility to undergo allogeneic stem cell transplantation. 7. Absence of uncontrolle…
TRX103 infusion via central line.