NT-I7 for the Treatment of Recurrent Squamous Cell Carcinoma of Head and Neck Undergoing Surgery

Part of paid clinical trials in San Francisco, California.

Sponsor
Hyunseok Kang, MD
Study ID
NCT04588038
Phase
PHASE1
Status
Terminated

Conditions

  • Recurrent Head and Neck Squamous Cell Carcinoma
  • Recurrent Hypopharyngeal Squamous Cell Carcinoma
  • Recurrent Laryngeal Squamous Cell Carcinoma
  • Recurrent Oral Cavity Squamous Cell Carcinoma
  • Recurrent Oropharyngeal Squamous Cell Carcinoma
  • Resectable Oropharyngeal Squamous Cell Carcinoma

Eligibility Criteria

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

Interventions

Study Details

This phase I trial evaluates the side effects of NT-I7 in treating patients with squamous cell carcinoma of head and neck that has come back (recurrent) who are undergoing surgery. NT-I7 is an immunotherapy drug that works by helping the immune system fight tumor cells. The body produces T-cells which play an important role in body's immune response and its ability to recognize tumor cells. This immunotherapy drug may boost body's T-cells to help fight cancer and enhance body's response to cancer.

Key Dates

Start date
Mar 12, 2021
Status verified
Feb 2025
Primary completion
Feb 3, 2025
Completion
Feb 3, 2025

Study Design

Enrollment
4 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (efineptakin alfa)
    Patients receive one dose of efineptakin alfa IM.

Primary Outcome Measure

Proportion of treatment-related adverse events [ Time Frame: Up to 35 days after the after the NT-I7 injection ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of California San FranciscoSan FranciscoCalifornia94143-

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