Trials / Active Not Recruiting

Active Not RecruitingNCT05334329

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

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

Status: Active Not Recruiting
Phase: Phase 1
Study type: Interventional
Enrollment: 6 (actual)

Sponsor: University of California, Irvine · Academic / Other
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVES: I. Assess the safety and determine the optimal biological dose (OBD) of COH06 as monotherapy and when given in combination with atezolizumab (Atezo). II. Assess the cellular kinetics of COH06 through the detection and measurement of persistence in the peripheral blood. SECONDARY OBJECTIVES: I. Estimate overall response (complete response \[CR\] + partial response \[PR\]) and disease control (CR + PR + stable disease \[SD\]) rates, including duration. II. Estimate the progression free survival (PFS) and overall survival (OS) rate, at 6-months and 1-year post (first) COH06 cell infusion. CORRELATIVE STUDY OBJECTIVES: I. Assess the phenotype and activation status of COH06 via flow cytometry, polymerase chain reaction (PCR), and cytokine analysis. II. Assess T cell activation by flow cytometry and cytokine analysis. OUTLINE: This is a phase I dose-escalation study of COH06. Patients receive fludarabine intravenously (IV) on days -5 to -3, cyclophosphamide IV on days -5 to -3, and COH06 IV on days 0, 7, 14, and 21 in the absence of disease progression or unacceptable toxicity. Patients assigned to dose level 4 also receive atezolizumab IV over 60 minutes on days 0, 14, 28, and 42 in the absence of disease progression or unacceptable toxicity. After completion of the study treatment, patients are followed for 30 days, every 8 weeks until disease progression, and then annually for 15 years.

Conditions

Interventions

Type	Name	Description
BIOLOGICAL	Antineoplastic Immune Cell	Given COH06 IV
BIOLOGICAL	Atezolizumab	Given IV
PROCEDURE	Biospecimen Collection	Correlative studies
DRUG	Cyclophosphamide	Given IV
DRUG	Fludarabine	Given IV

Timeline

Start date: 2022-07-20
Primary completion: 2026-06-14
Completion: 2026-06-14
First posted: 2022-04-19
Last updated: 2025-10-15

Locations

1 site across 1 country: United States

Regulatory

FDA-regulated drug study

Source: ClinicalTrials.gov record NCT05334329. Inclusion in this directory is not an endorsement.