NK Cells +/− Atezolizumab for Lung Cancer

Recruiting in Palo Alto (17 mi)

+1 other location

Miguel Villalona-Calero | UCI Health ...

Overseen byMiguel Villalona-Calero, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: City of Hope Medical Center

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This trial tests a new treatment using modified immune cells from umbilical cord blood to fight advanced lung cancer that didn't respond to previous treatments. Some patients will also receive a drug that boosts the immune system's ability to attack cancer. The goal is to find the best dose and see if the treatment is safe and effective.

Eligibility Criteria

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.

Inclusion Criteria

Your liver enzyme levels are not too high.

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

Your disease can be measured using specific criteria called RECIST 1.1.

+24 more

Exclusion Criteria

I experienced severe side effects from previous PD-1 inhibitor treatment.

Concomitant use of other investigational agents

My cancer has EGFR mutations or ALK translocations and treatments have not worked.

+13 more

Participant Groups

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.

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.