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NCT05050006 · ClinicalTrials.gov registry record · Phase 2

ITIL-168 in Advanced Melanoma

A Phase 2 study, sponsored by Instil Bio.

Terminated
Registry status
Phase 2
Development phase
29
Enrollment target

NCT05050006: Clinical Trial Phase 2 study, sponsored by Instil Bio.

NCT05050006 is a Phase 2 study that was terminated before completion, run by Instil Bio. The registered enrollment target is 29 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05050006, a Phase 2 study, was terminated before completion, sponsored by Instil Bio.

TERMINATED
Registry status
Phase 2
Development phase
29 participants
Enrollment target

Study Summary

DELTA-1 is a phase 2 clinical trial to evaluate the efficacy and safety of ITIL-168 in adult subjects with advanced melanoma who have previously been treated with a PD-1 inhibitor. ITIL-168 is a cell therapy derived from a patient's own tumor-infiltrating immune cells (lymphocytes; TILs).

Primary Outcome

Objective response rate (ORR), defined as the incidence of a complete response (CR) or a partial response (PR) per a modified Response Evaluation Criteria in Solid Tumors (RECIST v1.1) criteria, as assessed by central review.

Interventions

  • BIOLOGICAL ITIL-168

Trial Details

FieldValue
Enrollment Target 29 participants
Start Date 2021-10-07
Est. Completion 2023-02-27
Phase Phase 2
Instil Bio

2 total trials

Why NCT05050006 stopped before completion

NCT05050006 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (78% lower).

The record links to 0 conditions, and to 1 intervention - of which ITIL-168 is the first listed.

NCT05050006 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05050006 about?

NCT05050006 is a clinical study titled "ITIL-168 in Advanced Melanoma". DELTA-1 is a phase 2 clinical trial to evaluate the efficacy and safety of ITIL-168 in adult subjects with advanced melanoma who have previously been treated with a PD-1 inhibitor. ITIL-168 is a cell therapy derived from a patient's own tumor-infiltrating immune cells (lymphocytes; TILs).

What is the current status of trial NCT05050006?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 29 participants. The study started on 2021-10-07. Estimated completion is 2023-02-27.

What interventions are being tested in trial NCT05050006?

The interventions under investigation include: ITIL-168 (BIOLOGICAL).

Who is sponsoring clinical trial NCT05050006?

This trial is sponsored by Instil Bio, which has 2 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT05050006's enrollment target sits among peer trials

29 1669th of 2000 higher than 324 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 NCT05050006, the US trial registry maintained by the National Library of Medicine. NCT05050006 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.