MT2021-08T Cell Receptor Alpha/Beta Depletion PBSC Transplantation for Heme Malignancies
Trial Parameters
Brief Summary
This is a phase II, open-label, prospective study of T cell receptor alpha/beta depletion (TCR α/β TCD) peripheral blood stem cell (PBSC) transplantation for children and adults with hematological malignancies. This is a safety/feasibility study of the investigational procedure/product.
Eligibility Criteria
Inclusion Criteria: * Histological confirmation of hematological malignancies * Acute leukemias * Acute Myeloid Leukemia (AML) and related precursor neoplasms * Favorable risk AML is defined as having one of the following: * Acute lymphoblastic leukemia (ALL)/lymphoma * Myelodysplasia (MDS) IPSS INT-2 or High Risk (i.e. RAEB, RAEBt) or Refractory Anemia with severe pancytopenia, transfusion dependence, or high risk cytogenetics or molecular features. * Age 60 years of age or younger at the time of consent * Karnofsky performance status ≥ 70% or Lansky play score 50% for ≤16 years of age. * Adequate organ function Exclusion Criteria: * Pregnant or breastfeeding. * Active uncontrolled infection within 1 week of starting preparative therapy * Known seropositive for HIV or known active Hepatitis B or C infection with detectable viral load by PCR. * Any prior autologous or allogeneic transplant * CML blast crisis * Active central nervous system malignancy