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NCT06733935

A Phase 1/2 Study of NKX019 in Subjects With Immune-Mediated Diseases (Ntrust-2)

StatusRecruiting
PhasePhase 1/2
Primary completion (estimated)
Track this trial

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Record History

All 25 versions: 23 with changes below, 2 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Trial sites reduced: 18 → 12 locations
    • Eligibility criteria shortened, about 230 words
    • Secondary endpoints: 43 to 45
  2. Study sites: 17 to 18v24
  3. Study sites: 16 to 17v23
  4. Enrollment increased: 144 → 240 participants
    • Study sites: 15 to 16
    • Eligibility criteria expanded, about 332 words
    • Secondary endpoints: 29 to 43
    v22
  5. Study sites: 14 to 15v21
Show 17 earlier versionsHide 17 earlier versions
  1. Study sites: 13 to 14v20
  2. Study sites: 12 to 13v19
  3. Study sites: 11 to 12v18
  4. Study sites: 10 to 11v17
  5. Phase: Phase 1 to Phase 1/2v15 Show 5 more changesShow less
    • Enrollment target: 72 to 144
    • Eligibility criteria expanded, about 197 words
    • Secondary endpoints: 12 to 29
    • Study description shortened, about 11 words
    • Study title shortened, about 5 words
  6. Study sites: 9 to 10v13
  7. Study sites: 8 to 9v12
  8. Interventions: Fludarabine and Cyclophosphamide (Drug), NKX019 (Drug) to Cyclophosphamide (Drug), Fludarabine (Drug), NKX019 (Drug)v11
  9. Interventions: Cyclophosphamide (Drug), NKX019 (Drug) to Fludarabine and Cyclophosphamide (Drug), NKX019 (Drug)
    • Study description expanded, about 15 words
    v10
  10. Study sites: 7 to 8v9
  11. Study sites: 6 to 7v8
  12. Study sites: 5 to 6v7
  13. Study sites: 4 to 5v6
  14. Study sites: 3 to 4v5
  15. Site details revised at 2 of 3 sitesv4
  16. Study sites: 1 to 3v3
  17. Enrollment target: 90 to 72
    • Eligibility criteria expanded, about 58 words
    v2
  1. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Incidence of Dose-limiting toxicities (DLTs) [Safety and Tolerability]
Timeframe: The first 28 days after the first NKX019 dose
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Timeframe: From the first administration of NKX019 until the last administration of any study treatment + 30 days

Secondary (12)

For all participants with Interstitial Lung Disease (ILD)
For all participants with Systemic Sclerosis (SSc)
For all participants with Idiopathic Inflammatory Myopathies (IIM)
For all participants with ANCA-Associated Vasculitis (AAV)
For all participants with Rheumatoid Arthritis (RA)
Show 7 moreShow less
Evaluation of the effect of treatment on background therapies
Pharmacokinetics parameter: maximum concentration (Cmax)
Pharmacokinetics parameter: Time-to-maximum concentration (Tmax)
Pharmacokinetics parameter: Area under the curve (AUC)
Pharmacokinetics parameter: Half-life (t1/2)
Duration of persistence of NKX019 in peripheral blood
Assess humoral and cellular immunogenicity over time with validated methods that include: a cell-based flow cytometry assay for anti-NKX019 antibodies and an antigen bead-assay using flow cytometry for detection of anti-HLA antibodies

Arms and interventions

NKX019 - CAR NK cell therapyExperimental

Phase 1/2: NKX019 plus fludarabine and cyclophosphamide

Drugs: NKX019, Fludarabine, Cyclophosphamide

Sites

12 sites in 1 country