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NCT05334329 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Stage IV Lung Cancer AJCC v8 and Stage III Lung Cancer AJCC v8, sponsored by University of California, Irvine.

Active
Registry status
Phase 1
Development phase
6
Enrollment target
1
Study location

NCT05334329 is a Phase 1 study of Stage IV Lung Cancer AJCC v8 and Stage III Lung Cancer AJCC v8 that is active but no longer recruiting, run by University of California, Irvine. The registered enrollment target is 6 participants, below the 98-participant average among 81 other Stage IV Lung Cancer AJCC v8 trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT05334329, a Phase 1 study of Stage IV Lung Cancer AJCC v8 and Stage III Lung Cancer AJCC v8, is active but no longer recruiting, sponsored by University of California, Irvine.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
6 participants
Enrollment target
1
Study location

Study Summary

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.

Conditions Studied

Stage IV Lung Cancer AJCC v8 Stage III Lung Cancer AJCC v8 Metastatic Lung Non-Small Cell Carcinoma Stage IVA Lung Cancer AJCC v8 Stage IIIB Lung Cancer AJCC v8 Recurrent Lung Non-Small Cell Carcinoma Stage IIIA Lung Cancer AJCC v8 Stage IIIC Lung Cancer AJCC v8 Advanced Lung Non-Small Cell Carcinoma Refractory Lung Non-Small Cell Carcinoma

Interventions

  • DRUG Cyclophosphamide
  • DRUG Fludarabine
  • PROCEDURE Biospecimen Collection
  • BIOLOGICAL Atezolizumab
  • BIOLOGICAL Antineoplastic Immune Cell

Study Locations (1)

California

  • Chao Family Comprehensive Cancer Center University of California, Irvine - Orange

Trial Details

FieldValue
Enrollment Target 6 participants
Start Date 2022-07-20
Est. Completion 2026-06-14
Phase Phase 1

Sponsor

University of California, Irvine

368 total trials

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What the Registry Record Tells You About NCT05334329

The ClinicalTrials.gov registry entry for NCT05334329 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 98-participant average among 81 other Stage IV Lung Cancer AJCC v8 trials with a reported enrollment target (94% lower). The listed sponsor is University of California, Irvine, which has 368 total studies on file at ClinicalTrials.gov.

The record links to 10 conditions, with Stage IV Lung Cancer AJCC v8 appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.

NCT05334329 reports 1 study location spanning 1 distinct geographic area - top geographies include California.

Frequently Asked Questions

What is clinical trial NCT05334329 about?

NCT05334329 is a clinical study titled "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". 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 prev...

What is the current status of trial NCT05334329?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2022-07-20. Estimated completion is 2026-06-14.

What conditions does trial NCT05334329 study?

This clinical trial studies the following conditions: Stage IV Lung Cancer AJCC v8, Stage III Lung Cancer AJCC v8, Metastatic Lung Non-Small Cell Carcinoma, Stage IVA Lung Cancer AJCC v8, Stage IIIB Lung Cancer AJCC v8.

What interventions are being tested in trial NCT05334329?

The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Biospecimen Collection (PROCEDURE), Atezolizumab (BIOLOGICAL), Antineoplastic Immune Cell (BIOLOGICAL).

Who is sponsoring clinical trial NCT05334329?

This trial is sponsored by University of California, Irvine, which has 368 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05334329 being conducted?

This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.