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ACTIVE NOT RECRUITING
NCT05334329
PHASE1

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

Sponsor: University of California, Irvine

View on ClinicalTrials.gov

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.

Official title: Phase 1 Trial of Umbilical Cord Blood Natural Killer Cells (CB-NK) Expressing Soluble IL-15 (sIL-15) and PD-L1 +/- Atezolizumab in Non-Small Cell Lung Cancer Patients Refractory to PD-1/PD-L1 Immune Checkpoint Inhibitors

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

6

Start Date

2022-07-20

Completion Date

2026-06-14

Last Updated

2025-10-15

Healthy Volunteers

No

Interventions

BIOLOGICAL

Antineoplastic Immune Cell

Given COH06 IV

BIOLOGICAL

Atezolizumab

Given IV

PROCEDURE

Biospecimen Collection

Correlative studies

DRUG

Cyclophosphamide

Given IV

DRUG

Fludarabine

Given IV

Locations (1)

Chao Family Comprehensive Cancer Center University of California, Irvine

Orange, California, United States