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Cytokine

Immunotherapy Combination for Cancer

Phase 2
Recruiting
Led By Jason M Redman, M.D.
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
ECOG performance status <2
Participants must have metastatic or unresectable locally advanced Gastric/GEJ cancer that has been histologically confirmed.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 days after treatment (study calendar-last ae evaluation)
Awards & highlights

Study Summary

This trial is testing the effectiveness of using CAR-NK cells, in combination with pembrolizumab and N-803, to treat gastric or head and neck cancer.

Who is the study for?
Adults over 18 with advanced gastric or head and neck cancer, who've had standard treatment. They must have measurable disease, be in good physical condition (ECOG <2), and have proper organ function. Those with treated brain metastases without progression are eligible. Participants must not be pregnant, agree to contraception during the trial, and sign consent.Check my eligibility
What is being tested?
The trial tests a combination of immunotherapies: irradiated PD-L1 CAR-NK cells plus pembrolizumab plus N-803 for their effectiveness against recurrent/metastatic gastric or head and neck cancers. Treatments involve IV infusions of NK cells, IV pembrolizumab every 6 weeks, and subcutaneous N-803 every 4 weeks for up to two years.See study design
What are the potential side effects?
Potential side effects include reactions related to immune system activation such as inflammation in various organs, infusion-related reactions from the treatments given through veins or under the skin, fatigue from energy depletion due to therapy response, possible blood disorders affecting cell counts or clotting factors.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can do most of my daily activities without help.
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My stomach cancer cannot be surgically removed and has been confirmed by lab tests.
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I have had or was not eligible for first-line chemotherapy for my stomach cancer, and if HER2 positive, received HER2 therapy.
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My blood tests show my organs are functioning well.
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My head or neck cancer cannot be removed by surgery and has spread.
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I am 18 years old or older.
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My blood clotting levels are stable on my current warfarin treatment.
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I had hepatitis C but am cured, or I'm being treated with an undetectable viral load.
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I have had or was not eligible for first-line chemotherapy and have received PD-1 inhibitor therapy.
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My cancer is in the stomach or where the stomach meets the esophagus.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~until progression or death
This trial's timeline: 3 weeks for screening, Varies for treatment, and until progression or death for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
To determine the clinical response rate (CR+PR) with irradiated PD-L1 CAR-NK cells in combination with N-803 plus pembrolizumab in patients with head and neck squamous cell carcinoma and gastric/GEJ cancer.
Secondary outcome measures
To assess duration of response in patients with HNSCC and/or gastric/GEJ cancer treated with irradiated PD-L1 CAR-NK cells in combination with N-803 plus pembrolizumab
To assess the progression free survival (PFS) in patients with HNSCC and/or gastric/GEJ cancer treated with irradiated PD-L1 CAR-NK cells in combination with N-803 plus pembrolizumab
To assess the safety and tolerability of irradiated PD-L1 CAR-NK cells in combination with N-803 plus pembrolizumab in patients with head and neck squamous cell carcinoma and/or gastric/GEJ cancer

Trial Design

1Treatment groups
Experimental Treatment
Group I: 1/Arm 1Experimental Treatment3 Interventions
1-week lead in for PD-L1 CAR NK cell monotherapy followed by combination therapy of Pembrolizumab plus N-803
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
N-803
2021
Completed Phase 2
~30

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,665 Previous Clinical Trials
40,925,799 Total Patients Enrolled
Jason M Redman, M.D.Principal InvestigatorNational Cancer Institute (NCI)
4 Previous Clinical Trials
228 Total Patients Enrolled

Media Library

N-803 (Cytokine) Clinical Trial Eligibility Overview. Trial Name: NCT04847466 — Phase 2
Gastroesophageal Junction Cancers Research Study Groups: 1/Arm 1
Gastroesophageal Junction Cancers Clinical Trial 2023: N-803 Highlights & Side Effects. Trial Name: NCT04847466 — Phase 2
N-803 (Cytokine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04847466 — Phase 2

Frequently Asked Questions

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

Has the FDA sanctioned PD-L1 t-haNK?

"Although PD-L1 t-haNK is yet to be proven as efficacious, there are some sufficient scientific data supporting its safety; thus it has been given a score of 2."

Answered by AI

What indications is PD-L1 t-haNK typically employed for?

"The utilization of PD-L1 t-haNK therapy has been shown to be effective in treating malignancies, unresectable melanomas and microsatellite instability high diseases."

Answered by AI

How many participants are enrolled in this research endeavor?

"Affirmative. According to the details provided on clinicaltrials.gov, this medical study commenced recruitment on December 14th 2021 and is still open for enrollment as of October 5th 2022. A total of 55 individuals are sought from one research centre/hospital."

Answered by AI

Can you provide an overview of prior research relating to PD-L1 t-haNK?

"Currently, there are 977 clinical trials involving PD-L1 t-haNK. Of those in progress, 123 have reached the Phase 3 stage of testing. The majority of these studies originate from Houston, Texas though 35820 locations worldwide currently engage with this treatment."

Answered by AI

Are further enrollees being admitted to this research study?

"This medical study, which was initially published on December 14th 2021, is currently enrolling participants. The details of the trial were most recently updated on October 5th 2022."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Immunotherapy Combination: Irradiated PD-L1 CAR-NK Cells Plus Pembrolizumab Plus N-803 for Subjects With Recurrent/Metastatic Gastric or Head and Neck Cancer
2021. "Immunotherapy Combination: Irradiated PD-L1 CAR-NK Cells Plus Pembrolizumab Plus N-803 for Subjects With Recurrent/Metastatic Gastric or Head and Neck Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04847466.
~13 spots leftby Jan 2025
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