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Tumor Infiltrating Lymphocyte Therapy for Pediatric High Risk Solid Tumors

NCT06047977 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-07-16

No results posted yet for this study

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

BIOLOGICAL

Tumor Infiltrating Lymphocytes, Fludarabine, Cyclophosphamide, Interleukin-2

Lymphodepleting Chemotherapy with Fludarabine/Cyclophosphamide followed by TIL and Post-TIL Interleukin-2 (IL-2)

Sponsors & Collaborators

  • Swim Across America

    collaborator OTHER

  • Benjamin Gilkey Fund

    collaborator UNKNOWN

  • Cannonball Kids' Cancer Foundation

    collaborator OTHER

  • H. Lee Moffitt Cancer Center and Research Institute

    lead OTHER

Principal Investigators

  • Jonathan Metts, MD · Moffitt Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Year
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-02
Primary Completion
2026-12-01
Completion
2027-12-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06047977 on ClinicalTrials.gov