Personalized NK Cell Therapy in CBT
M.D. Anderson Cancer Center
Summary
This phase II clinical trial studies how well personalized natural killer (NK) cell therapy works after chemotherapy and umbilical cord blood transplant in treating patients with myelodysplastic syndrome, leukemia, lymphoma or multiple myeloma. This clinical trial will test cord blood (CB) selection for human leukocyte antigen (HLA)-C1/x recipients based on HLA-killer-cell immunoglobulin-like receptor (KIR) typing, and adoptive therapy with CB-derived NK cells for HLA-C2/C2 patients. Natural killer cells may kill tumor cells that remain in the body after chemotherapy treatment and lessen the risk of graft versus host disease after cord blood transplant.
Description
PRIMARY OBJECTIVES: I. Progression-free survival (PFS) time. SECONDARY OBJECTIVES: I. Overall survival (OS) time. II. Transplant related mortality (TRM). III. Graft versus host disease (GVHD). IV. Infection OUTLINE: Patients are assigned to 1 of 3 preparative regimens. MYELOABLATIVE REGIMEN 1: Patients receive anti-thymocyte globulin intravenously (IV) over 4 hours on days -9 and -8, fludarabine phosphate IV over 1 hour, clofarabine IV over 1 hour, and busulfan IV over 3 hours on days -7 to -4. Patients undergo total body irradiation (TBI) on day -3. NON-MYELOABLATIVE REGIMEN 2: Patients…
Eligibility
- Age range
- 15–80 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Patients must have one of the following hematologic malignancies: acute myelogenous leukemia (AML), induction failure, high-risk for relapse first remission (with intermediate-risk or high-risk cytogenetics including complex karyotype, abnormal \[abn\]\[3q\], -5/5q-, -7/7q-, abn\[12p\], abn\[17p\], myeloid/lymphoid or mixed-lineage leukemia \[MLL\] gene re-arrangement and t \[6;9\]47, fms related tyrosine kinase 3 \[flt3\] mutation positive and/or evidence of minimal residual disease by flow cytometry), secondary leukemia from prior chemotherapy and/or arising from myelo…
Interventions
- BiologicalAllogeneic Natural Killer Cell Line NK-92
Given IV
- BiologicalAnti-Thymocyte Globulin
Given IV
- DrugBusulfan
Given IV
- DrugClofarabine
Given IV
- DrugCyclophosphamide
Given IV
- DrugFludarabine Phosphate
Given IV
- OtherLaboratory Biomarker Analysis
Correlative studies
Location
- M D Anderson Cancer CenterHouston, Texas