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ACTIVE NOT RECRUITING
NCT06566092
PHASE1

Study of Autologous Tumor-Infiltrating Lymphocytes in Pediatric, Adolescent, and Young Adult Participants

Sponsor: Iovance Biotherapeutics, Inc.

View on ClinicalTrials.gov

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

Interventions

BIOLOGICAL

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