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Monoclonal Antibodies

Dose Level 0: PD-L1 t-haNK + N-803 + Cetuximab for Head and Neck Squamous Cell Carcinoma

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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

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

Primary outcome measures

Objective Response Rate (ORR)

Secondary outcome measures

Grade 3-5 Treatment-related Toxicity Rate

Median Duration of Response (DOR)

Median Overall Survival (OS)

+1 more

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

~30

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

ImmunityBio, Inc.Industry Sponsor

63 Previous Clinical Trials

5,111 Total Patients Enrolled

Glenn J. HannaLead Sponsor

3 Previous Clinical Trials

95 Total Patients Enrolled

Glenn J Hanna, MDPrincipal InvestigatorDana-Farber Cancer Institute

4 Previous Clinical Trials

102 Total Patients Enrolled

Frequently Asked Questions

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

Are there openings for new participants in this ongoing clinical trial?

"As per information on clinicaltrials.gov, recruitment for this particular trial is currently closed. This study was first listed on 1st March 2024 and last revised on 1st February 2024. Despite its temporary inactivity, it's important to note that there are a substantial number of other trials - precisely 3767 - actively seeking participants presently."

Answered by AI

What are the safety considerations for patients receiving Dose Level -1: PD-L1 t-haNK + N-803 + Cetuximab?

"As we are in a Phase 2 trial, the safety assessment for Dose Level -1: PD-L1 t-haNK + N-803 + Cetuximab is rated at 2 by our team at Power. This signifies some existing safety data with no evidence yet supporting efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

PD-L1 t-haNK, N-803 IL-15sa and Cetuximab for Recurrent, Metastatic HNSCC

Glenn J. Hanna 2024. "PD-L1 t-haNK, N-803 IL-15sa and Cetuximab for Recurrent, Metastatic HNSCC". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06239220.

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