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Tumor Infiltrating Lymphocyte Therapy for Pediatric High Risk Solid Tumors

StatusRecruiting
PhasePhase 1
Started2025-06-02
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 33 months later Dec 1, 2026 → Sep 1, 2029
See other at-risk trials from H. Lee Moffitt Cancer Center and Research Institute

Amendment history

2026-09-18
Primary completion pushed: 2026-12-01 → 2029-09-01
Completion pushed: 2027-12-01 → 2029-09-01
2025-07-14
Study Status, Contacts/Locations v7
Study sitescontacts updated at 1 of 1 site
2025-06-04
Not Yet Recruiting→Recruiting Study Identification, Study Status, Contacts/Locations v6
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2025-06→confirmed 2025-06-02
Study sites2→1
2025-02-21
Study Status v5
Start date2025-02-01→2025-06
2024-12-30
Study Identification, Study Status, Sponsor/Collaborators v4
Start date2024-10-01→2025-02-01
Lead sponsorJohns Hopkins All Children's Hospital→H. Lee Moffitt Cancer Center and Research Institute
Show 3 earlier versions
2024-03-18
Study Status, Eligibility v3
Start date2024-02-01→2024-10-01
Eligibility criteria+50 characters
[...] rced expiratory volume (FEV1), forced vital capacity (FVC), DLCOdiffusing capacity of the lungs for carbon monoxide (diffusion capacityDLCO) > 50% predicted (corrected for hemoglobin); if unable to p [...] Radiation therapy: At least 28 days after local palliative radiotherapy (XRT) (small port); 6 weeks must have elapsed since treatment with therapeutic doses of 131I131 I-MIBG; At least 42 days must have elapsed if other substanti [...] nsplant and 42 days for autologous stem cell infusion after 131Iodine131 Iodine meta-iodobenzylguanidine (MIBG) therapy. Investigational Ag [...] tainty the study PI should be no [...]
2023-12-14
Study Status v2
Start date2023-12-01→2024-02-01
2023-09-25
Study Status, Conditions v1
Re-verified, no change to tracked fields
2023-09-15
Original filing
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
Trial Details
NCT Number NCT06047977
Lead Sponsor H. Lee Moffitt Cancer Center and Research Institute
Collaborators: Swim Across America, Benjamin Gilkey Fund, Cannonball Kids' Cancer Foundation
Conditions Lymphocytes
Enrollment 30 participants
Start Date 2025-06-02
Primary Completion 2029-09-01 (estimated)
Study Completion 2029-09-01 (estimated)
Updated on ClinicalTrials.gov 2026-09-17