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NCT06047977 · ClinicalTrials.gov registry record · Phase 1
Tumor Infiltrating Lymphocyte Therapy for Pediatric High Risk Solid Tumors
A Phase 1 study of Lymphocytes, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT06047977: Recruiting Phase 1 study of Lymphocytes, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
NCT06047977 is a Phase 1 study of Lymphocytes that is actively recruiting participants, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 30 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06047977, a Phase 1 study of Lymphocytes, is actively recruiting participants, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
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
Primary Outcome
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).
Conditions Studied
Interventions
- BIOLOGICAL Tumor Infiltrating Lymphocytes, Fludarabine, Cyclophosphamide, Interleukin-2
Study Locations (1)
Florida
- Johns Hopkins All Children's Hospital - St. Petersburg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2025-06-02 |
| Est. Completion | 2027-12-01 |
| Phase | Phase 1 |
What NCT06047977 shows while recruiting
NCT06047977 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower).
The record links to 1 condition, with Lymphocytes appearing as the primary indexed condition, and to 1 intervention - of which Tumor Infiltrating Lymphocytes, Fludarabine, Cyclophosphamide, Interleukin-2 is the first listed.
NCT06047977 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT06047977 about?
NCT06047977 is a clinical study titled "Tumor Infiltrating Lymphocyte Therapy for Pediatric High Risk Solid Tumors". 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-ris...
What is the current status of trial NCT06047977?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2025-06-02. Estimated completion is 2027-12-01.
What conditions does trial NCT06047977 study?
This clinical trial studies the following conditions: Lymphocytes.
What interventions are being tested in trial NCT06047977?
The interventions under investigation include: Tumor Infiltrating Lymphocytes, Fludarabine, Cyclophosphamide, Interleukin-2 (BIOLOGICAL).
Who is sponsoring clinical trial NCT06047977?
This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06047977 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06047977's enrollment target sits among peer trials
30 1332nd of 2000 higher than 561 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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