A Phase 1 Study of NKX019, a CD19 Chimeric Antigen Receptor Natural Killer (CAR NK) Cell Therapy, in Subjects With Autoimmune Disease

Status: Recruiting
Location: See all (13) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

This is an open-label, multi-center, non-randomized Phase 1 study to determine the safety and tolerability of NKX019 (allogeneic CAR NK cells targeting CD19) in participants with active lupus nephritis (LN) or primary membranous nephropathy (pMN).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• Age ≥18 and ≤65

• Progression despite maximal tolerated doses of renin-angiotensin system (RAS) blockade agents

• For participants taking chronic corticosteroids for management of the disease under study, stable dose for ≥ 14 days before the screening visit with planned reduction to ≤ 5 mg prednisone by the time of LD start

• Negative SARS-CoV-2 test

⁃ LN-specific Inclusion Criteria:

• Score of 10 or more points on the American College of Rheumatology (ACR) 2019 classification criteria for SLE

• Active nephritis Class III, IV, and/or V using the 2018 International Society of Nephrology and Renal Pathology Society (ISN/RPS) criteria (Bajema 2018) as evidenced on kidney biopsy during screening or within 6 months before screening. Per NIH indices, subjects must have at least moderate activity score and no more than moderate chronicity index

• Active renal disease as defined by urinary protein:creatinine ratio (UPCR) ≥ 1.5 g/g or proteinuria ≥1.5 g/day and ≤ 7 g/day

• Positive antinuclear antibodies (ANA) ≥ 1:80 OR anti-dsDNA OR anti-Smith (anti-Sm)

• Refractory LN defined as having received ≥ 2 prior therapies for LN

⁃ pMN-specific Inclusion Criteria:

• Evidence of pMN by renal biopsy during screening or within 6 months before screening

• Active renal disease at screening defined by UPCR ≥ 3.5 g/g or proteinuria ≥ 3.5 g/day

• Positive anti-PLA2R antibodies

• Refractory or intolerant to either B cell-depleting agents and/or cyclophosphamide and/or calcineurin inhibitors defined as not achieving a complete remission after 180 days, or partial remission after 90 days

Locations
United States
Arkansas
Nkarta Investigational Site
RECRUITING
Little Rock
Florida
Nkarta Investigational Site
RECRUITING
Gainesville
Nkarta Investigational Site
RECRUITING
Miami
Georgia
Nkarta Investigational Site
RECRUITING
Atlanta
Illinois
Nkarta Investigational Site
RECRUITING
Chicago
Louisiana
Nkarta Investigational Site
RECRUITING
New Orleans
Massachusetts
Nkarta Investigational Site
RECRUITING
Worcester
Michigan
Nkarta Investigational Site
RECRUITING
Ann Arbor
New York
Nkarta Investigational Site
RECRUITING
New York
Nkarta Investigational Site
RECRUITING
Stony Brook
Texas
Nkarta Investigational Site
RECRUITING
Dallas
Nkarta Investigational Site
RECRUITING
Houston
Other Locations
Puerto Rico
Nkarta Investigational Site
RECRUITING
Manatí
Contact Information
Primary
Nkarta Central Contact
clinicaltrials@nkartatx.com
Only Use Email
Time Frame
Start Date: 2024-06-13
Estimated Completion Date: 2027-04
Participants
Target number of participants: 48
Treatments
Experimental: NKX019 - CAR NK cell therapy
Phase 1: NKX019 plus fludarabine and cyclophosphamide
Sponsors
Leads: Nkarta, Inc.

This content was sourced from clinicaltrials.gov

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