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
- Efineptakin alfa — BIOLOGICALGiven via intramuscular injection
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)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of California San Francisco | San Francisco | California | 94143 | - |
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