M.D. Anderson Cancer Center
To find a recommended dose of PRAME-TCR-NK cells that can be given to patients with AML or MDS.
PRIMARY OBJECTIVE: I. To assess dose-limiting toxicity (DLT) and determine the safety, day 30 response rate, day 180 treatment failure rate (defined as disease progression or death) and optimal cell dose of T cell receptor (TCR) modified cord blood-natural killer (CB-NK) cells (TCR-NK) targeting PRAME in patients with relapsed/refractory myeloid malignances, for each of the following diseases; AML, and MDS/CMML. The day 30 response rate and day 180 treatment failure rate will be estimated, and the estimates will be used to identify an optimal dose of PRAME-TCR-NK cells. SECONDARY OBJECTIVES:…
Inclusion Criteria: 1. 18- 80 years of age. English and non-English speaking patients are eligible. 2. Patients with one of the following hematological malignances: AML, MDS/CMML. Patients must meet disease specific eligibility criteria (see below) 3. 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 therap…
Given by IV
Given by IV
Given by IV
Given by mouth
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