To find a recommended dose of PRAME-TCR-NK cells that can be given to patients with AML or MDS.
18- 80 years of age. English and non-English speaking patients are eligible.
Patients with one of the following hematological malignances: AML, MDS/CMML. Patients must meet disease specific eligibility criteria (see below)
Patients at least 7 days from last cytotoxic chemotherapy at the time of starting lymphodepleting chemotherapy, except for Hydroxyurea which is allowed for peripheral blood count control in AML patients until the day prior to administration of lymphodepleting chemotherapy. Patients may continue tyrosine kinase inhibitors or other targeted therapies until up to three days prior to administration of lymphodepleting chemotherapy.
Localized radiotherapy to one or more disease sites is allowed prior the infusion provided that there are additional disease sites that are not irradiated to assess response.
Positive beta HCG in female of child-bearing potential defined as not postmenopausal for 24 months or no previous surgical sterilization or lactating females.
Presence of clinically significant Grade 3 or greater toxicity from the previous treatment, as determined by PI.
Presence of uncontrolled fungal, bacterial, viral, or other infection not responding to appropriate therapy.
Known active hepatitis B or C.
Single group
Cyclophosphamide
DrugGiven by IV
Fludarabine phosphate
DrugGiven by IV
Decitabine
DrugGiven by IV
Dexamethasone
DrugGiven by mouth
Safety and adverse events (AEs)
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
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