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

StatusRecruiting
PhasePhase 2
Started2024-02-16
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 5 months later Jul 31, 2026 → Dec 31, 2026
See other at-risk trials from Dana-Farber Cancer Institute

Amendment history

2026-08-17
Study Status v9
Primary completion pushed: 2026-07-31 → 2026-12-31
Completion pushed: 2027-01-31 → 2027-03-31
2026-07-29
Study Status, Sponsor/Collaborators, Contacts/Locations v8
Sponsor changed: Glenn J. Hanna → Dana-Farber Cancer Institute+14 characters
WasGlenn J. Hanna
NowDana-Farber Cancer Institute
Study sitescontacts updated at 2 of 2 sites
2026-06-10
Study Status v7
Re-verified, no change to tracked fields
2026-02-24
Study Identification, Study Status, Study Description, Arms and Interventions v6
InterventionsCetuximab (Drug), N-803 (Biological), PD-L1 t-haNK (Biological)→Cetuximab (Drug), NAI (Biological), PD-L1 t-haNK (Biological)
Study description-8 characters
This research study is to test the safety and efficacy of the combination of PD-L1 t-haNK (modified immune cells), N-803NAI (a manufactured protein that stimulates the immune system), [...] ncer. PD-L1 t-haNK in combination with the immunotherapies, N-803NAI and cetuximab, may work together to increase the activity a [...] Administration (FDA) has not approved PD-L1 t-haNK cells or N-803NAI as a treatment for advanced head and neck cancer, but the F [...] s research study. ImmunityBio is supplying PD-L1 t-haNK and N-803NAI for the study.
Study title-2 characters
PD-L1 t-haNK, N-803NAI IL-15sa and Cetuximab for Recurrent, Metastatic HNSCC
2025-08-26
Study Status, Eligibility v5
Eligibility criteria-17 characters
[...] in 14 days prior to study registration): a. ANC ≥1,000/mcL b. ALC ≥ 600/mcl c. Hemoglobin ≥9 g/dL dc. Platelets ≥100,000/mcL ed. Total bilirubin ≤ upper limit of normal (ULN) fe. AST(SGOT)/ALT(SGPT) ≤2.5x institutional ULN (or ≤1.5x inst [...]
Show 4 earlier versions
2025-08-18
Study Status v4
Primary completion date2025-07-31→2026-07-31
2025-05-27
Study Identification, Study Status, Oversight, Eligibility, Contacts/Locations v3
Eligibility criteria+150 characters
[...] in 14 days prior to study registration): a. ANC ≥1,000/mcL b. ALC ≥ 600/mcl c. Hemoglobin ≥9 g/dL cd. Platelets ≥100,000/mcL de. Total bilirubin ≤ upper limit of normal (ULN) ef. AST(SGOT)/ALT(SGPT) ≤2.5x institutional ULN (or ≤1.5x inst [...] stitutional ULN) or ≤5x ULN for those with liver metastases fg. Serum creatinine ≤1.5x ULN or creatinine clearance ≥60 mL/ [...] r serum pregnancy test within 7 days of study registration. Female subjects should not become pregnant or nurse a baby during the study and through 120 days after the last dose of study drugs. Male subjects should use a condom as a contracep [...] [...]
Study sitescontacts updated at 2 of 2 sites
Study titlerevised
PD-L1 Tt-haNK, N-803 IL-15sa and Cetuximab for Recurrent, Metastatic HNSCC
2024-10-23
Study Identification, Study Status, Oversight, Eligibility, Contacts/Locations v2
Eligibility criteria+7 characters
[...] SCC. Have received radiation therapy (RT) within 10 days of studystarting registrationprotocol therapy. Solid organ transplant (allograft) recipients. Participant [...]
Study sitescontacts updated at 2 of 2 sites
Study titlerevised
PD-L1 tT-haNK, N-803 IL-15sa and Cetuximab for Recurrent, Metastatic HNSCC
2024-03-18
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2024-03-01→confirmed 2024-02-16
Study sitesdetails revised at 2 of 2 sites
2024-02-01
Original filing
The purpose of this research study is to test the safety and efficacy of the combination of PD-L1 t-haNK (modified immune cells), NAI (a manufactured protein that stimulates the immune system), and cetuximab (a targeted antibody) in treating advanced head and neck cancer. The names of the therapies involved in this study are: * PD-L1 t-haNK cell therapy (a NK cell therapy infusion) * NAI (a type of recombinant human superagonist) * Cetuximab (a type of antibody)
Trial Details
NCT Number NCT06239220
Lead Sponsor Dana-Farber Cancer Institute
Collaborators: ImmunityBio, Inc.
Conditions Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma, Metastatic Head and Neck Cancer, Recurrent Head and Neck Cancer, Metastatic Head-and-neck Squamous-cell Carcinoma, Recurrent Head and Neck Squamous Cell Carcinoma
Enrollment 25 participants
Start Date 2024-02-16
Primary Completion 2026-12-31 (estimated)
Study Completion 2027-03-31 (estimated)
Updated on ClinicalTrials.gov 2026-08-18