Spots Global Cancer Trial Database for Study of LN-145/LN-145-S1 Autologous Tumor Infiltrating Lymphocytes in the Treatment of Squamous Cell Carcinoma of the Head & Neck
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Trial Identification
Brief Title: Study of LN-145/LN-145-S1 Autologous Tumor Infiltrating Lymphocytes in the Treatment of Squamous Cell Carcinoma of the Head & Neck
Official Title: A Phase 2, Multicenter Study to Evaluate the Efficacy and Safety of Autologous Tumor Infiltrating Lymphocytes (LN-145/LN-145-S1) for the Treatment of Patients With Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck
Study ID: NCT03083873
Study Description
Brief Summary: Multicenter, multicohort, non-randomized, prospective, open label, interventional study evaluating adoptive cell therapy (ACT) with autologous tumor infiltrating lymphocytes (TIL) infusion (LN-145/LN-145-S1) followed by IL-2 after a non-myeloablative (NMA) lymphodepletion preparative regimen for the treatment of patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck
Detailed Description: LN-145/LN-145-S1 is an adoptive cell transfer therapy that utilizes an autologous TIL manufacturing process, as originally developed by the NCI, for the treatment of patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck. The cell transfer therapy used in this study involves patients receiving a NMA lymphodepletion preparative regimen, followed by infusion of autologous TIL followed by the administration of a regimen of IL-2.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Alabama, Birmingham, Alabama, United States
University of California San Diego, La Jolla, California, United States
University of California, Los Angeles, Los Angeles, California, United States
University of Southern California, Los Angeles, California, United States
University of Colorado, Aurora, Colorado, United States
Christiana Care Health System, Newark, Delaware, United States
Moffitt Cancer Center, Tampa, Florida, United States
Northwestern University, Chicago, Illinois, United States
University of Chicago, Chicago, Illinois, United States
Indiana University, Indianapolis, Indiana, United States
University of Kansas, Westwood, Kansas, United States
University of Louisville, Louisville, Kentucky, United States
Louisiana State University - Health Sciences Center, New Orleans, Louisiana, United States
University of Maryland, Baltimore, Maryland, United States
Barbara Ann Karmanos Cancer Institute, Detroit, Michigan, United States
Morristown Medical Center, Morristown, New Jersey, United States
University of North Carolina, Chapel Hill, North Carolina, United States
Providence Cancer Center Oncology and Hematology Care Clinic, Portland, Oregon, United States
UPMC Hillman Cancer Center, Pittsburgh, Pennsylvania, United States
Avera Cancer Institute, Sioux Falls, South Dakota, United States
University of Washington, Seattle, Washington, United States
Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Contact Details
Name: Iovance Biotherapeutics Medical Monitor
Affiliation: Iovance Biotherapeutics
Role: STUDY_DIRECTOR
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