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)
Participants must have an existing histologically confirmed diagnosis of head and neck squamous cell carcinoma (HNSCC) with evidence of recurrent, metastatic (R/M) or locoregionally advanced, incurable or unresectable disease from any mucosal subsite including oral cavity, oropharynx, larynx, hypopharynx, nasal cavity, and the paranasal sinuses.
Participants must have at least one RECIST v1.1 measurable lesion, as defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) ≥ 1 cm with CT scans or MR imaging.
Must have had at least 1, but no more than 2, prior lines of prior systemic therapy for R/M HNSCC; one of these lines should have included anti-PD-1/L1 therapy.
a.Platinum-based therapy as part of definitive/adjuvant or curative-intent treatment can count as 1 prior line of therapy if the subject progressed within 6 months of receiving therapy.
Have been previously treated with 3 or more lines of systemic therapy for R/M HNSCC.
Have received radiation therapy (RT) within 10 days of starting protocol therapy.
Solid organ transplant (allograft) recipients.
Participant has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging and off systemic steroids for at least 3 weeks prior to study registration) and have no evidence of new or enlarging brain metastases.
Sequential
PD-L1 t-haNK
Biological/VaccineAllogeneic, stable, clonal natural killer cell line product, via intravenous infusion (into the vein) per protocol.
Cetuximab
DrugEpidermal growth factor receptor, via intravenous (into the vein) infusion per institutional standard of care.
NAI
Biological/VaccineRecombinant human superagonist, via subcutaneous injection (under the skin) per protocol.
Objective Response Rate (ORR)
The objective response rate (ORR) was defined as the proportion of participants achieving complete response (CR) or partial response (PR) based on RECISTv1.1 criteria.
Grade 3-5 Treatment-related Toxicity Rate
All grade 3-5 adverse events (AE) with treatment attribution of possibly, probably or definite based on CTCAEv5 that are not resolved in accordance with treatment guidelines were counted. Rate is the proportion of treated participants experiencing at least one of these adverse events as defined during the time of observation.
Median Duration of Response (DOR)
DOR estimated using the Kaplan Meier method, is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started, or death due to any cause. Participants without events reported are censored at the last disease evaluation).
Median Progression-Free Survival (PFS)
Progression-free survival based on the Kaplan-Meier method is defined as the duration between registration and documented disease progression (PD) defined per RANO-BM criteria. or death, or is censored at time of last disease assessment.
Median Overall Survival (OS)
Overall Survival (OS) based on the Kaplan-Meier method is defined as the time from study entry to death or censored at date last known alive.
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Dana-Farber Cancer Institute
Lead sponsor
ImmunityBio, Inc.
Collaborator
