A Phase 1/2 Study of NKX019, a CD19 Chimeric Antigen Receptor Natural Killer [CAR NK] Cell Therapy, in Subjects with Immune-Mediated Diseases (NCT06733935)

The Ntrust-2 study is looking for adults ages 18–70 to take part in research on an investigational cell therapy, called NKX019. NKX019 is being studied to see if it can safely target the root cause of systemic sclerosis (SSc or scleroderma), idiopathic inflammatory myopathy (IIM or myositis) or ANCA-associated vasculitis (AAV or polyangiitis). NKX019 is made from natural killer (NK) cells, which are white blood cells and a normal part of everyone’s immune system. For this study, NK cells are collected from healthy donors and specially processed into NKX019. NKX019 is made from white blood cells called natural killer (NK) cells. NK cells are the immune system’s first responders and possess a unique, natural ability to target and kill disease-causing cells. NK cells are a normal part of the immune system and are present in everyone. The NK cells used in NKX019 are collected from healthy donors and then processed for use in NK cell therapy.

Trial phase

Phase 1

Trial participation type

This trial has been designed for the Clinical Research of a Drug.

Principal investigator

Dr Yuan Lim

Key inclusion data

Age 18 to 70 years old; Have been diagnosed with systemic sclerosis (SSc or scleroderma), idiopathic inflammatory myopathy (IIM or myositis), or ANCA-associated vasculitis (AAV or polyangiitis); Have received prior autoimmune disease treatments that may have not worked well for you.