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

Status: Recruiting
Location: See all (12) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• Age ≥18 and ≤70

• For participants taking corticosteroids, 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

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

⁃ SSc:

• Meets the 2013 American College of Rheumatology (ACR)/European Alliance of Associations for Rheumatology (EULAR) classification criteria for SSc

• Meet criteria a and/or b:

‣ Severe skin involvement defined as mRSS ≥ 30 or active skin disease defined as mRSS ≥ 15 at screening and one or more of the following within the prior 6 months of screening:

• An increase in mRSS of ≥ 3 units

∙ Involvement of 1 new body area with ≥ 2 mRSS units

∙ 2 new body areas with ≥ 1 mRSS unit

⁃ Moderate to severe Interstitial Lung Disease (ILD) defined by evidence of ILD on High-resolution computed tomography (HRCT) and FVC \< 70% of predicted or DLCO (hemoglobin or alveolar volume corrected) \< 70% of predicted or ILD on HRCT and progressive ILD meeting at least 2 of the following 3 criteria within the prior 6 months of screening:

• Worsening respiratory symptoms

∙ Evidence of progression on HRCT, or

∙ Evidence of absolute decline in FVC ≥ 5% (Raghu et al 2022)

• Presence of anti-nuclear antibody ≥ 2 x upper limit of normal (ULN)

• 10 years or less since the first non-Raynaud's sign or symptom

• Inadequate response or intolerance to at least one treatment, including cyclophosphamide, methotrexate, MMF/mycophenolic acid, nintedanib, rituximab, or tocilizumab

⁃ IIM:

• Diagnosis for IIM as per 2017 ACR/EULAR Classification Criteria

• One positive myositis antibody

• Activity defined as manual muscle testing (MMT-8) score \<136/150

• Creatinine kinase or aldolase ≥ 1.5 x ULN and Clinician Global Assessment ≥ 2 cm with at least one of the following:

‣ Evidence on magnetic resonance imaging (MRI) of active myositis within the last 6 months

⁃ Electromyography (EMG) with active myositis within the last 6 months

⁃ Muscle Biopsy of active myositis within last 6 months

• Refractory disease defined as ≥ 6 months failure (or intolerance) to at least 2 immunosuppressive therapies (including glucocorticoids)

⁃ AAV:

• Meets the 2022 ACR/EULAR classification criteria for Granulomatosis with Polyangiitis (GPA) (Robson 2022) or Microscopic Polyangiitis (MPA) (Suppiah 2022)

• Relapsed or refractory AAV despite repeated treatment with immunosuppressive agents or requiring prolonged and/or repeated courses of unacceptable doses of glucocorticoids to maintain disease control

• Positive test for anti-proteinase-3 (PR3-ANCA) or anti-myeloperoxidase (MPO-ANCA) at screening

• Have at least one major item, or at least 3 other items, or at least 2 renal items on the BVAS version 3

Locations
United States
California
Nkarta Investigational Site
RECRUITING
Orange
Florida
Nkarta Investigational Site
RECRUITING
Miami
Nkarta Investigational Site
RECRUITING
Plantation
Illinois
Nkarta Investigational Site
RECRUITING
Chicago
Kansas
Nkarta Investigational Site
RECRUITING
Fairway
Michigan
Nkarta Investigational Site
RECRUITING
Ann Arbor
Minnesota
Nkarta Investigational Site
RECRUITING
Minneapolis
New Jersey
Nkarta Investigational Site
RECRUITING
Hackensack
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: 2024-11-04
Estimated Completion Date: 2028-10
Participants
Target number of participants: 144
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