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Monoclonal Antibodies

PD-L1 t-haNK + N-803 + Cetuximab for Head and Neck Cancer

Phase 2

Recruiting

Led By Glenn J Hanna, MD

Research Sponsored by Glenn J. Hanna

Eligibility Criteria Checklist

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

Must have

Be ≥18 years of age on the day of signing informed consent.

Female subjects of childbearing potential should have a negative urine or serum pregnancy test within 7 days of study registration. Male subjects should use a condom as a contraceptive during the study and through 6 months after the last dose of study drugs.

Must not have

Solid organ transplant (allograft) recipients.

Any known positive test result for hepatitis B virus or hepatitis C virus indicating presence of virus, e.g., hepatitis B surface antigen (HBsAg, Australia antigen) positive, or hepatitis C antibody (anti-HCV) positive (except if HCV-RNA negative). Patients with HIV are eligible if their plasma HIV viral load is undetectable at baseline on antiretroviral therapy.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to test the safety and effectiveness of combining three treatments - PD-L1 t-haNK cell therapy, N-803, and cetuximab - for treating advanced head and neck

Who is the study for?

This trial is for adults with advanced head and neck squamous cell carcinoma that has come back or spread. Participants should have tried other treatments without success. They must be in good physical condition, with no major organ dysfunction, and able to handle biopsies.

What is being tested?

The study tests a combination of three therapies: PD-L1 t-haNK (modified immune cells), N-803 (an immune system booster), and cetuximab (a targeted antibody). It aims to see if this mix can safely improve outcomes for patients with recurrent or metastatic head and neck cancer.

What are the potential side effects?

Potential side effects may include reactions at the infusion site, flu-like symptoms from immune stimulation, allergic responses to cetuximab, fatigue, skin rash, as well as possible impacts on normal organ functions.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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I am not pregnant or will use contraception during and 6 months after the study.

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I have a confirmed diagnosis of advanced or incurable head and neck cancer.

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I have a tumor that can be measured by scans.

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I've had 1-2 treatments for head/neck cancer, including one targeting PD-1/L1.

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have received an organ transplant from another person.

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I have hepatitis B or C, or I am HIV positive but undetectable with treatment.

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I have had 3 or more treatments for my head and neck cancer.

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I have cancer that has spread to my brain or spinal cord.

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I do not have any uncontrolled illnesses or recent serious heart issues.

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I have undergone radiation therapy within the last 10 days.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

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

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Objective Response Rate (ORR)

Secondary study objectives

Grade 3-5 Treatment-related Toxicity Rate

Median Duration of Response (DOR)

Median Overall Survival (OS)

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Dose Level 0: PD-L1 t-haNK + N-803 + CetuximabExperimental Treatment3 Interventions

Dose level modifications of PD-L1 t-haNK and N-803 due to toxicities will follow protocol specifications, starting at Dose Level 0 and de-escalating to Dose Level -1. Participants will complete: * Baseline visit. * Imaging scans every 8 weeks while on study. * Cycle 1 through End of Treatment: --Days 1 and 15 of 28 day cycle in the following order: Predetermined dose of PD-L1 t-haNK 1x daily, predetermined dose of N-803 1x daily, and predetermined dose of Cetuximab 1x daily. * End of Treatment visit with assessments. * Follow up: follow up every 3-4 months for up to 3 years after end of treatment. Longer-term follow-up every 6-12 months for up to 15 years.

Group II: Dose Level -1: PD-L1 t-haNK + N-803 + CetuximabExperimental Treatment3 Interventions

Dose level modifications of PD-L1 t-haNK and N-803 due to toxicities will follow protocol specifications. Participants will complete: * Baseline visit. * Imaging scans every 8 weeks while on study. * Cycle 1 through End of Treatment: --Days 1 and 15 of 28 day cycle in the following order: Predetermined dose of PD-L1 t-haNK 1x daily, predetermined dose of N-803 1x daily, and predetermined dose of Cetuximab 1x daily. * End of Treatment visit with assessments. * Follow up: follow up every 3-4 months for up to 3 years after end of treatment. Longer-term follow-up every 6-12 months for up to 15 years.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cetuximab

2011

Completed Phase 3

~2480

N-803

2021

Completed Phase 2

~130