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Genetically Engineered Natural Killer (NK) Cells With or Without Atezolizumab for the Treatment of Non-small Cell Lung Cancer Previously Treated With PD-1 and/or PD-L1 Immune Checkpoint Inhibitors

StatusActive, Not Recruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 1 year 5 months later Jun 14, 2027 → Nov 30, 2028
See other at-risk trials from University of California, Irvine

Record History

  1. Primary and study completion pushed from Jun 14, 2027 to Nov 30, 2028 Study description revised · Publications: details revised at 2 of 2 entries · Eligibility criteria shortened, about 5 words Show 3 more changesShow less
    • Study description revised
    • Publications: details revised at 2 of 2 entries
    • Eligibility criteria shortened, about 5 words
  2. Primary and study completion dates: Jun 14, 2026 to Jun 14, 2027v12
  3. Lead sponsor: City of Hope Medical Center to University of California, Irvine Study site revisedv11 Show 1 more changeShow less
    • Study site revised

    See this version in full on ClinicalTrials.gov ↗

  4. Collaborators: 2 to 1v10 See this version in full on ClinicalTrials.gov ↗
  5. Primary and study completion dates: Sep 30, 2025 to Jun 14, 2026v9
Show 7 earlier versionsHide 7 earlier versions
  1. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 21 to confirmed 6 · Site details revisedv8 Show 2 more changesShow less
    • Enrollment target: estimated 21 to confirmed 6
    • Site details revised
  2. Re-verified, no change to tracked fieldsv7
  3. Primary and study completion dates: Jan 28, 2025 to Sep 30, 2025 Study site revisedv6 Show 1 more changeShow less
    • Study site revised

    See this version in full on ClinicalTrials.gov ↗

  4. Start date changed from estimate of Jul 17, 2022 to Jul 20, 2022v5
  5. Trial status: Not Yet Recruiting to Recruiting Site details revisedv4 Show 1 more changeShow less
    • Site details revised
  6. Collaborators: 1 to 2v3 See this version in full on ClinicalTrials.gov ↗
  7. Study title expanded, about 2 wordsv2 See this version in full on ClinicalTrials.gov ↗
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This phase I trial studies the side effects and best dose of COH06 with or without atezolizumab in patients with non-small cell lung cancer previously treated with PD-1 and/or PD-L1 immune checkpoint inhibitors that has spread to other places in the body (advanced) and that has not responded to previous treatment (refractory). NK cells are infection fighting blood cells that can kill tumor cells. The NK cells given in this study, COH06, will come from umbilical cord blood and will have a new gene put in them that makes them express PD-L1, and express and secrete IL-15. NK cells that express PD-L1 may kill more tumor cells, and IL-15 may allow the NK cells to live longer. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving COH06 without or without atezolizumab may help control the disease in patients with non-small cell lung cancer.
Trial Details
NCT Number NCT05334329
Lead Sponsor University of California, Irvine
Collaborators: National Cancer Institute (NCI)
Conditions Advanced Lung Non-Small Cell Carcinoma, Metastatic Lung Non-Small Cell Carcinoma, Recurrent Lung Non-Small Cell Carcinoma, Refractory Lung Non-Small Cell Carcinoma, Stage III Lung Cancer AJCC v8, Stage IIIA Lung Cancer AJCC v8, Stage IIIB Lung Cancer AJCC v8, Stage IIIC Lung Cancer AJCC v8 +3 more
Enrollment 6 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov