A Phase 1/2 Study of NKX019 in Subjects With Autoimmune Disease (Ntrust-1)
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorNkarta, Inc.
About this trial
This is a Phase 1/2, open-label, multi-center, multi-cohort, non-randomized dose escalation and dose expansion basket study to determine the safety and tolerability of NKX019 (allogeneic CAR NK cells targeting CD19) in participants with autoimmune diseases.
Eligibility criteria
Qualifiers
Age ≥18 and ≤75
Signed informed consent form and ability to adhere to the study visit schedule and comply with other protocol requirements
Women of childbearing potential must have negative pregnancy tests at screening and baseline, and agree to abstinence or acceptable birth control from 2 weeks prior to the first dose through 1 year after the last dose
Progression despite maximal tolerated doses of renin-angiotensin system (RAS) blockade agents
Disqualifiers
eGFR < 45 ml/min/1.73 m²
Currently requiring renal dialysis or expected to require dialysis during the study period
Previous solid organ or hematopoietic cell transplant or planned transplant within study treatment period
Congenital or acquired immunodeficiency resulting in severe infection or those receiving chronic immunoglobulin replacement therapy
Trial design
Treatments tested in this trial
- NKX019
- Fludarabine, Cyclophosphamide
Treatment groups
120 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov