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NCT04052334 · ClinicalTrials.gov registry record · Phase 1

Lymphodepletion Plus Adoptive Cell Therapy With High Dose IL-2 in Adolescent and Young Adult Patients With Soft Tissue Sarcoma

A Phase 1 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.

Completed
Registry status
Phase 1
Development phase
9
Enrollment target

NCT04052334: Completed Phase 1 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.

NCT04052334 is a Phase 1 study that has completed, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 9 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04052334, a Phase 1 study, has completed, sponsored by H. Lee Moffitt Cancer Center and Research Institute.

COMPLETED
Registry status
Phase 1
Development phase
9 participants
Enrollment target

Study Summary

This is a single-arm trial that will evaluate the safety and feasibility of the Tumor-infiltrating lymphocyte (TIL) treatment and the persistence of TIL survival in vivo following treatment

Primary Outcome

Participants able to safely tolerate preparatory lymphodepletion, infusion of tumor-infiltrating lymphocytes (TIL) and subsequent IL-2, as measured by adverse events and serious adverse events.

Interventions

  • DRUG Cyclophosphamide
  • DRUG Fludarabine
  • DRUG Interleukin-2
  • DRUG TIL

Trial Details

FieldValue
Enrollment Target 9 participants
Start Date 2019-09-27
Est. Completion 2023-06-16
Phase Phase 1

What the finished NCT04052334 record still lists

NCT04052334 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% lower).

The record links to 0 conditions, and to 4 interventions - of which Cyclophosphamide is the first listed.

NCT04052334 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04052334 about?

NCT04052334 is a clinical study titled "Lymphodepletion Plus Adoptive Cell Therapy With High Dose IL-2 in Adolescent and Young Adult Patients With Soft Tissue Sarcoma". This is a single-arm trial that will evaluate the safety and feasibility of the Tumor-infiltrating lymphocyte (TIL) treatment and the persistence of TIL survival in vivo following treatment

What is the current status of trial NCT04052334?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 9 participants. The study started on 2019-09-27. Estimated completion is 2023-06-16.

What interventions are being tested in trial NCT04052334?

The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Interleukin-2 (DRUG), TIL (DRUG).

Who is sponsoring clinical trial NCT04052334?

This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04052334's enrollment target sits among peer trials

9 1955th of 2000 higher than 42 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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Source: ClinicalTrials.gov NCT04052334, the US trial registry maintained by the National Library of Medicine. NCT04052334 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.