NCT06566092

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

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

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Iovance Biotherapeutics, Inc. · Industry
• Sex: All
• Age: 6 Months – 21 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Soft Tissue Sarcoma
• Primary Central Nervous System Carcinoma
• Melanoma
• Rhabdomyosarcoma
• Ewing Sarcoma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-03-28
• Primary completion: 2026-07-01
• Completion: 2028-07-01
• First posted: 2024-08-22
• Last updated: 2026-04-06

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study