M.D. Anderson Cancer Center
To find the highest tolerable dose and recommended dose of PRAME-TCR-NK cells that can be given to participants with recurrent and/or refractory melanoma. The safety and tolerability of PRAME-TCR-NK cells will also be studied.
Primary Objectives 1\. To determine he safety, tolerability, optimal cell dose (OCD), maximum tolerated dose (MTD), and recommended Phase 2 dose (RP2D) of PRAME-TCR-NK cells in participants with relapsed and/or refractory melanoma. Secondary Objectives 1. To determine preliminary antitumor activity of PRAME-TCR-NK cells in participants with relapsed and/or relapsed and/or refractory melanoma. 2. To quantify the persistence of infused allogeneic donor PRAME-TCR-MK cells in the peripheral blood of the recipient. 3. To evaluate tissue and blood-based biomarkers associated with response and res…
Inclusion Criteria: 1. Participants must be 18 years or older. 2. Participants must be willing and able to provide informed consent. 3. Participants must have HLA A\*02:01. 4. Participants must have histologically documented locally advanced, unrespectable, or metastatic melanoma that is relapsed and/or refractory to immune checkpoint inhibitor (ICI) therapy including either anti-PD-1 either with or without anti-CTLA-4 blocking antibody and/or anti-LAG-3 antibody. During dose escalation, participants with cutaneous, mucosal, or unknown primary melanoma will be enrolled. Participants with…
Given by IV
Given by IV
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