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NCT04847466 · ClinicalTrials.gov registry record · Phase 2
Immunotherapy Combination: Irradiated PD-L1 CAR-NK Cells Plus Pembrolizumab Plus N-803 for Subjects With Recurrent/Metastatic Gastric or Head and Neck Cancer
A Phase 2 study of Gastroesophageal Junction (GEJ) Cancers and Advanced HNSCC, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 2
- Development phase
- 18
- Enrollment target
- 1
- Study location
NCT04847466: Active Phase 2 study of Gastroesophageal Junction (GEJ) Cancers and Advanced HNSCC, sponsored by National Cancer Institute (NCI).
NCT04847466 is a Phase 2 study of Gastroesophageal Junction (GEJ) Cancers and Advanced HNSCC that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 18 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04847466, a Phase 2 study of Gastroesophageal Junction (GEJ) Cancers and Advanced HNSCC, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 18 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: Immunotherapy is a powerful tool in the fight against cancer. It uses the body s own immune system to fight the cancer. Unfortunately, cancer cells can find ways to escape from destruction by the body s immune system, even when immunotherapy is used. Natural killer (NK) cells are an important part of the body s immune system and can help fight cancer. In combination with immunotherapy, researchers are using engineered NK cells that recognize and kill cancer cells trying to escape destruction by the immune system. Objective: To test the effectiveness of irradiated PD-L1 CAR-NK cells, combined with pembrolizumab and N-803, in people with advanced forms of gastric or head and neck cancer. Eligibility: Adults ages 18 and older with advanced gastric or head and neck cancer who have already had standard cancer treatment. Design: Participants will be screened with a medical history and physical exam. Their symptoms and ability to do normal activities will be assessed. They will have blood and urine tests. They will have imaging scans of the chest, abdomen, and pelvis. Participants will get PD-L1 CAR-NK cells by intravenous (IV) infusion. They will get the cells once a week for 6 weeks. Then they will get the cells once every 2 weeks. Before each infusion, an IV catheter will be placed in a large arm vein for infusion of these treatments. Participants will get pembrolizumab by IV every 6 weeks. They will get N-803 under the skin every 4 weeks. Participants will get the study drugs for up to 2 years. They will have study visits every 1-2 weeks during treatment. They will have a safety visit 28 days after treatment ends. After treatment ends, participants will be contacted for follow-up every 2 months for a year. Then they will be contacted every 6 months. They will have tumor scans every 6-12 weeks until their cancer gets worse.
Primary Outcome
Clinical response rate (CR+PR)
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG N-803
- BIOLOGICAL PD-L1 t-haNK
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2021-12-14 |
| Est. Completion | 2027-12-31 |
| Phase | Phase 2 |
What the registry record for NCT04847466 still lists
NCT04847466 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% lower).
The record links to 2 conditions, with Gastroesophageal Junction (GEJ) Cancers appearing as the primary indexed condition, and to 3 interventions - of which Pembrolizumab is the first listed.
NCT04847466 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT04847466 about?
NCT04847466 is a clinical study titled "Immunotherapy Combination: Irradiated PD-L1 CAR-NK Cells Plus Pembrolizumab Plus N-803 for Subjects With Recurrent/Metastatic Gastric or Head and Neck Cancer". Background: Immunotherapy is a powerful tool in the fight against cancer. It uses the body s own immune system to fight the cancer. Unfortunately, cancer cells can find ways to escape from destruction by the body s immune system, even when immunotherapy is used. Natural killer (NK) cells are an im...
What is the current status of trial NCT04847466?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 18 participants. The study started on 2021-12-14. Estimated completion is 2027-12-31.
What conditions does trial NCT04847466 study?
This clinical trial studies the following conditions: Gastroesophageal Junction (GEJ) Cancers, Advanced HNSCC.
What interventions are being tested in trial NCT04847466?
The interventions under investigation include: Pembrolizumab (DRUG), N-803 (DRUG), PD-L1 t-haNK (BIOLOGICAL).
Who is sponsoring clinical trial NCT04847466?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04847466 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04847466's enrollment target sits among peer trials
18 1898th of 2000 higher than 98 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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