Tumor Infiltrating Lymphocyte Therapy for Pediatric High Risk Solid Tumors

Phase 1

Not yet recruiting

• Conditions: Lymphocytes
• Interventions: Biological: Tumor Infiltrating Lymphocytes, Fludarabine, Cyclophosphamide, Interleukin-2

• Registration Number: NCT06047977
• Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-15
• Study First Submitted QC: 2023-09-15
• Study First Posted: 2023-09-21
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-21
• Last Update Posted: 2025-02-24
• Study Start: 2025-06
• Primary Completion: 2026-12-01
• Study Completion: 2027-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TIL Therapy	Tumor Infiltrating Lymphocytes, Fludarabine, Cyclophosphamide, Interleukin-2	TIL therapy with lymphodepleting chemotherapy and Interleukin 2

Primary Outcome Measures

Name	Time	Method
Safety of TIL therapy in Pediatric Solid Tumors	3 years	The regimen will be declared safe if \<33% of patients (0 or 1 out of maximum 6 patients on the safety phase) experience a dose-limiting toxicity (DLT).

Secondary Outcome Measures

Name	Time	Method
Feasibility of Generating TIL Product from Pediatric Solid Tumors	3 years	The TIL acquisition/production strategies will be considered feasible if 50% or more of all tumors collected on the prospective biobanking study generate a primary TIL culture that is satisfactory for rapid expansion for use on the Phase I trial.
Disease Response to TIL Therapy	3 years	For recurrent patients with measurable disease, Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 will be used. For all patients, event-free survival (EFS) will be reported.
Toxicity of TIL Therapy in Pediatric Solid Tumors	3 years	Toxicities of all grades related to therapy and all Grade 3 and higher toxicities will be collected.

Trial Locations

Locations (1)

Johns Hopkins All Children's Hospital; 🇺🇸 Saint Petersburg, Florida, United States