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NCT06151847 · ClinicalTrials.gov registry record · Phase 2

Lifileucel With Reduced Dose Fludarabine/Cyclophosphamide Lymphodepletion and Interleukin-2 for the Treatment of Patients With Unresectable or Metastatic Melanoma

A Phase 2 study, sponsored by University of Kansas Medical Center.

Completed
Registry status
Phase 2
Development phase
11
Enrollment target

NCT06151847: Completed Phase 2 study, sponsored by University of Kansas Medical Center.

NCT06151847 is a Phase 2 study that has completed, run by University of Kansas Medical Center. The registered enrollment target is 11 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06151847, a Phase 2 study, has completed, sponsored by University of Kansas Medical Center.

COMPLETED
Registry status
Phase 2
Development phase
11 participants
Enrollment target

Study Summary

This phase II trial tests how well lifileucel, with reduce dose fludarabine and cyclophosphamide for lymphodepletion and interleukin-2, work for treating patients with melanoma that cannot be removed by surgery (unresectable) or that has spread from where it first started (primary site) to other places in the body (metastatic).Lifileucel is made up of specialized immune cells called lymphocytes or T cells that are taken from a patient's tumor, grown in a manufacturing facility and infused back into the preconditioned patient to attack the tumor. Giving Lifileucel with a reduced dose of fludarabine and cyclophosphamide for lymphodepletion and interleukin -2 is being studied in patients with unresectable or metastatic melanoma.

Primary Outcome

The TCR population is calculated as the frequencies of unique CDR3 sequences as measured by HTBIvc assay. Will be summarized with respect to mean and standard deviation. The percentage changes will also be presented with respect to visual diagrams for each person, e.g., waterfall plot

Interventions

  • DRUG Cyclophosphamide
  • DRUG Fludarabine
  • PROCEDURE Biospecimen Collection
  • BIOLOGICAL Interleukin-2
  • PROCEDURE Echocardiography

Trial Details

FieldValue
Enrollment Target 11 participants
Start Date 2023-12-21
Est. Completion 2025-07-10
Phase Phase 2
University of Kansas Medical Center

408 total trials

What the finished NCT06151847 record still lists

NCT06151847 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower).

The record links to 0 conditions, and to 5 interventions - of which Cyclophosphamide is the first listed.

NCT06151847 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT06151847 about?

NCT06151847 is a clinical study titled "Lifileucel With Reduced Dose Fludarabine/Cyclophosphamide Lymphodepletion and Interleukin-2 for the Treatment of Patients With Unresectable or Metastatic Melanoma". This phase II trial tests how well lifileucel, with reduce dose fludarabine and cyclophosphamide for lymphodepletion and interleukin-2, work for treating patients with melanoma that cannot be removed by surgery (unresectable) or that has spread from where it first started (primary site) to other pla...

What is the current status of trial NCT06151847?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 11 participants. The study started on 2023-12-21. Estimated completion is 2025-07-10.

What interventions are being tested in trial NCT06151847?

The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Biospecimen Collection (PROCEDURE), Interleukin-2 (BIOLOGICAL), Echocardiography (PROCEDURE).

Who is sponsoring clinical trial NCT06151847?

This trial is sponsored by University of Kansas Medical Center, which has 408 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT06151847's enrollment target sits among peer trials

11 1967th of 2000 higher than 33 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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 NCT06151847, the US trial registry maintained by the National Library of Medicine. NCT06151847 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.