NCT06047977

Tumor Infiltrating Lymphocyte Therapy for Pediatric High Risk Solid Tumors

Tumor Infiltrating Lymphocytes in Pediatric Malignant Solid Tumors: A Prospective Biobanking Study and Phase I Clinical Trial

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: All
• Age: 1 Year – 21 Years
• Healthy volunteers: Not accepted

Summary

Part One of this study will determine the feasibility of creating Tumor-Infiltrating Lymphocyte (TIL) product prospectively from high-risk pediatric solid tumors. Part Two of this study will determine the safety of TIL therapy with lymphodepleting chemotherapy and post-TIL Interleukin-2 in high-risk pediatric solid tumors

Conditions

• Lymphocytes

Interventions

Type	Name	Description
BIOLOGICAL	Tumor Infiltrating Lymphocytes, Fludarabine, Cyclophosphamide, Interleukin-2	Lymphodepleting Chemotherapy with Fludarabine/Cyclophosphamide followed by TIL and Post-TIL Interleukin-2 (IL-2)

Timeline

• Start date: 2025-06-02
• Primary completion: 2026-12-01
• Completion: 2027-12-01
• First posted: 2023-09-21
• Last updated: 2025-07-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study