Phase 1 Dose Escalation and Expansion Study of PRAME T Cell Receptor (TCR) Engineered NK Cells in Participants With Recurrent and/or Refractory Melanoma (PRAMETIME-Mel)

Description

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 resistance to PRAME-TCR-NK cell infusion.