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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Glenn J. Hanna
Study ID
NCT06239220
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • PD-L1 t-haNK — BIOLOGICAL
    Allogeneic, stable, clonal natural killer cell line product, via intravenous infusion (into the vein) per protocol.
  • Cetuximab — DRUG
    Epidermal growth factor receptor, via intravenous (into the vein) infusion per institutional standard of care.
  • NAI — BIOLOGICAL
    Recombinant human superagonist, via subcutaneous injection (under the skin) per protocol.

Study Details

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)

Key Dates

Start date
Feb 16, 2024
Status verified
Jun 2026
Primary completion
Jul 31, 2026
Completion
Jan 31, 2027

Study Design

Enrollment
25 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Level 0: PD-L1 t-haNK + NAI + Cetuximab
    Dose level modifications of PD-L1 t-haNK and NAI 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 NAI 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.
  • Experimental: Dose Level -1: PD-L1 t-haNK + NAI + Cetuximab
    Dose level modifications of PD-L1 t-haNK and NAI 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 NAI 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.

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: Disease will be evaluated through imaging every 2 cycles on day 1 and 15 (each cycle is 28 days) and through study completion (an average of 1 year). ORR expected to be observed up to 1 year. ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Brigham and Women's HospitalBostonMassachusetts02115
Glenn J Hanna, MD
[email protected]
617-632-3779
Glenn J Hanna, MD (PRINCIPAL_INVESTIGATOR)
Dana Farber Cancer InstituteBostonMassachusetts02115
Glenn J Hanna, MD
[email protected]
617-632-3779
Glenn J Hanna, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Boston, MA

By condition
Head and neck cancer
By specialty
OncologyENT
By research site
Brigham and Women's Hospital· Boston, MADana Farber Cancer Institute· Boston, MA

Related Studies