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Study of Autologous Tumor-Infiltrating Lymphocytes in Pediatric, Adolescent, and Young Adult Participants
Sponsor: Iovance Biotherapeutics, Inc.
Summary
This study is planned to test the safety and tolerability of the TIL regimen. The study will also test how well TIL fights cancer. The study will enroll children, teenagers, and young adults with solid tumors that have returned or are not responding to treatment for whom no effective standard-of-care treatment options exist. Study details include: * The study will last up to 2 years after the TIL infusion (Day 0) for each person. * The treatment will last up to 10 days for each person. * Study visits will be every 2 weeks until Day 42, every 6 weeks until Month 6, and every 3 months until Year 2.
Official title: A Phase 1, Multicenter, Open-label, 2-stage, Single-arm Study to Evaluate the Safety and Tolerability of an Autologous Tumor-infiltrating Lymphocytes (TIL) Regimen and Preliminary Antitumor Activity of TIL in Pediatric, Adolescent, and Young Adult Participants With Relapsed or Refractory Solid Tumors
Key Details
Gender
All
Age Range
6 Months - 21 Years
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2024-03-28
Completion Date
2028-07
Last Updated
2026-04-06
Healthy Volunteers
No
Conditions
Interventions
LN-145/LN-144
A tumor sample is resected from each patient and cultured ex vivo to expand the population of tumor infiltrating lymphocytes.
Locations (5)
Children's Hospital of Colorado
Aurora, Colorado, United States
Johns Hopkins All Children's Hospital
St. Petersburg, Florida, United States
Rutgers Cancer Institute
New Brunswick, New Jersey, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States