NKARTA: This Phase I trial is evaluating how safe and tolerable an experimental targeted therapy (NKX101) is in people with acute myeloid leukaemia or myelodysplastic syndromesA Phase 1 Study of NKX101, an Activating Chimeric Receptor Natural Killer Cell Therapy, in Subjects With Hematological Malignancies or Dysplasias

Summary

This trial has one experimental arm with two parts. Part 1 is a dose-finding phase with two dosing regimens, utilizing modified "3+3" enrolment schema. Either haplo-matched related donor derived or unrelated off-the-shelf donor derived NKX101 will be used. Part 2 is a dose expansion phase to further evaluate safety and tolerability, cellular kinetics, pharmacodynamics and anti-tumour response in expansion cohorts of patients. Either haplo-matched related donor derived or unrelated off-the-shelf donor derived NKX101 will be used. NKX101 is an investigational allogeneic CAR NK product targeting NKG2D ligands on cancer cells. The starting dose of NKX101 in Part 1/Regimen A is 1 × 10^8 NK cells (2 × 10^6/kg for patients < 50="" kg)="" administered="" as="" 3="" weekly="" doses.="" the="" starting="" dose="" of="" nkx101="" in="" part="" 1/regimen="" b="" is="" 1.5="" ã—="" 10^8="" nk="" cells="" (3="" ã—="" 10^6/kg="" for="" patients="">< 50="" kg)="" administered="" as="" 2="" weekly="" doses.="" part="" 2="" will="" use="" the="" maximum="" tolerated="" dose="" (mtd)="" or="" recommended="" phase="" 2="" dose="" (rp2d)="" of="" nkx101="" as="" determined="" in="" part="">

Treatment Type

Systemic therapy (chemotherapy, hormone therapy or immunotherapy)