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CAR T-cell Therapy

NK Cells +/− Atezolizumab for Lung Cancer

Phase 1

Recruiting

Led By Miguel A Villalona-Calero

Research Sponsored by City of Hope Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Lung non-small cell carcinoma (NSCLC) patients with advanced, metastatic, or recurrent disease, previously treated with a PD-1 or PD-L1 immune checkpoint inhibitor, either as single agent or in combination with chemotherapy or other immunotherapy or experimental agents

Eastern Cooperative Oncology Group (ECOG) 0 or 1

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

Study Summary

This trial is testing the side effects and best dose of COH06, a new treatment for non-small cell lung cancer that has spread and is refractory to previous treatment. COH06 is a form of immunotherapy that uses NK cells, which are infection-fighting blood cells, from umbilical cord blood. The new gene in the COH06 NK cells makes them express PD-L1, which allows them to kill more tumor cells. IL-15 in the COH06 NK cells allows them to live longer. Atezolizumab is a monoclonal antibody that may help the body's immune

Who is the study for?

Adults with advanced non-small cell lung cancer that has worsened after treatment with PD-1/PD-L1 inhibitors. They must not have HIV, active hepatitis B or C, and should have normal organ function. Pregnant or breastfeeding women can't join, nor can those with certain mutations in their tumors unless specific treatments failed.Check my eligibility

What is being tested?

The trial is testing COH06 (genetically modified NK cells) alone or combined with Atezolizumab to see if they help fight lung cancer better. It's a phase I study to determine the right dose and observe side effects when treating patients whose cancer didn't respond to previous therapies.See study design

What are the potential side effects?

Possible side effects include immune reactions due to NK cells or Atezolizumab, such as inflammation in various organs, infusion-related reactions, fatigue, blood disorders like anemia and low platelet counts, increased risk of infections and potential allergic responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have advanced NSCLC and was treated with PD-1 or PD-L1 inhibitors.

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I am fully active or restricted in physically strenuous activity but can do light work.

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I am 18 years old or older.

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I have recovered from side effects of cancer treatment, except for hair loss.

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My cancer has grown despite treatment with a PD-1/PD-L1 inhibitor.

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I haven't had chemotherapy or immunotherapy in the last 3 weeks.

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My body has recovered from previous medication side effects, except for hair loss or mild anemia.

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My lung cancer is confirmed to be non-small cell type.

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My kidneys are working well, as shown by a test.

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My blood clotting time is near normal and I'm not on blood thinners.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Dose limiting toxicities

Incidence of adverse events - ASTCT

Incidence of adverse events - CTCAE

Secondary outcome measures

Disease Control Rate (DCR)

Overall Response Rate (ORR)

Overall Survival (OS)

+1 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (fludarabine, cyclophosphamide, COH06, atezolizumab)Experimental Treatment5 Interventions

Patients receive fludarabine 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Atezolizumab

2017

Completed Phase 3

~5860

Biospecimen Collection

2004

Completed Phase 2

~1730

Cyclophosphamide

1995

Completed Phase 3

~3770

Fludarabine

2012

Completed Phase 3

~1100

0 / 10Eligibility criteria met

Find a Location

Who is running the clinical trial?

City of Hope Medical CenterLead Sponsor

565 Previous Clinical Trials

1,921,439 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,663 Previous Clinical Trials

40,925,884 Total Patients Enrolled

CytoImmune TherapeuticsUNKNOWN

Media Library

COH06 (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05334329 — Phase 1

Lung Cancer Research Study Groups: Treatment (fludarabine, cyclophosphamide, COH06, atezolizumab)

Lung Cancer Clinical Trial 2023: COH06 Highlights & Side Effects. Trial Name: NCT05334329 — Phase 1

COH06 (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05334329 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the Federal Drug Administration sanctioned Antineoplastic Immune Cell for medical use?

"Since this is a Phase 1 trial, with limited data on both safety and efficacy, the team at Power has assigned Antineoplastic Immune Cell a rating of 1."

Answered by AI

Are there currently any openings to participate in this experiment?

"Affirmative. Information posted to clinicaltrials.gov asserts that this experiment, which was initially published on July 20th 2022, is presently recruiting test subjects. A total of 21 individuals need to be sourced from 1 medical centre."

Answered by AI

How many individuals is this research focusing on?

"That is correct. According to clinicaltrials.gov, this medical experiment which was first advertised on July 20th 2022, is currently seeking out enrollees. A total of 21 patients are required from a single clinic site."

Answered by AI

What are the targeted outcomes of this experiment?

"The primary evaluation measure for this clinical trial over a two year period is the Incidence of Adverse Events using CTCAE. Secondary outcomes include Overall Response Rate (ORR), Progression-Free Survival (PFS) and Overall Survival (OS). ORR is measured in accordance with RECIST 1.1 criteria, PFS represents how long patients live without worsening conditions, OS accounts for length of survival from diagnosis or start of treatment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2022. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05334329.