A Phase 1/2 Study of NKX019, a CD19 Chimeric Antigen Receptor Natural Killer (CAR NK) Cell Therapy, in Subjects With Autoimmune Disease

Status: Recruiting
Location: See all (14) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

This is an open-label, multi-center, non-randomized, Phase 1/2 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: 70
Healthy Volunteers: f
View:

• Age ≥18 and ≤70

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

• For participants taking chronic corticosteroids for management of the disease under study, the prednisone (or equivalent) dose must be ≤40 mg/day at 6 weeks prior to Screening and stable for ≥ 14 days before start of Screening

• Negative SARS-CoV-2 test

• For subjects on immunosuppressives or immunomodulators (other than corticosteroids), all doses must be stable for ≥ 4 weeks prior to Screening

⁃ LN-specific Inclusion Criteria:

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

• Active biopsy proven lupus nephritis Class III or Class IV with or without Class 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. For subjects with primarily Class III or Class IV LN, the biopsy must have at least mild to moderate activity score (≥4/24) and no more than moderate chronicity index (≤ 6/12) per NIH indices

• Active renal disease as defined by urinary protein:creatinine ratio (UPCR) ≥ 1.5 g/g or proteinuria ≥1.5 g/day on a 24-hour collection and ≤ 7 g/day by either measure

• 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 (immunosuppressant and corticosteroid/or immunomodulatory agent, and corticosteroid at therapeutic range for at least 90 days), and had an inadequate response to therapy despite being on a therapeutic dose for ≥ 90 days

⁃ 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 spot UPCR ≥ 3.5 g/g or proteinuria ≥ 3.5 g/day on a 24-hour collection

• Positive anti-PLA2R antibodies

• Refractory or intolerant to at least one induction therapy for pMN (immunosuppressant and corticosteroid or immunomodulatory agent and/corticosteroid) and 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
Nkarta Investigational Site
RECRUITING
Plantation
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: 96
Treatments
Experimental: NKX019 - CAR NK cell therapy
Phase 1/2: NKX019 plus fludarabine and cyclophosphamide
Sponsors
Leads: Nkarta, Inc.

This content was sourced from clinicaltrials.gov