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NCT04111510 · ClinicalTrials.gov registry record · Phase 2

Autologous Tumor Infiltrating Lymphocytes in Patients With Pretreated Metastatic Triple Negative Breast Cancer

A Phase 2 study, sponsored by Yale University.

Completed
Registry status
Phase 2
Development phase
6
Enrollment target

NCT04111510: Completed Phase 2 study, sponsored by Yale University.

NCT04111510 is a Phase 2 study that has completed, run by Yale University. The registered enrollment target is 6 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04111510, a Phase 2 study, has completed, sponsored by Yale University.

COMPLETED
Registry status
Phase 2
Development phase
6 participants
Enrollment target

Study Summary

This study will investigate the safety and efficacy of TIL therapy in patients with metastatic TNBC who have progressed on at least one and no more than three prior systemic anticancer therapies.

Primary Outcome

To evaluate the efficacy of autologous LN-145 as a single therapy in Metastatic Triple Negative Breast Cancer (TNBC) patients by determining the objective response rate (ORR), using the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, as assessed by the Investigator. Upon results entry, the time frame was updated to reflect the latest time point that a participant was assessed for ORR in the study.

Interventions

  • DRUG Tumor infiltrating lymphocytes (TIL) LN-145

Trial Details

FieldValue
Enrollment Target 6 participants
Start Date 2019-12-23
Est. Completion 2023-05-11
Phase Phase 2
Yale University

1,492 total trials

What the finished NCT04111510 record still lists

NCT04111510 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower).

The record links to 0 conditions, and to 1 intervention - of which Tumor infiltrating lymphocytes (TIL) LN-145 is the first listed.

NCT04111510 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04111510 about?

NCT04111510 is a clinical study titled "Autologous Tumor Infiltrating Lymphocytes in Patients With Pretreated Metastatic Triple Negative Breast Cancer". This study will investigate the safety and efficacy of TIL therapy in patients with metastatic TNBC who have progressed on at least one and no more than three prior systemic anticancer therapies.

What is the current status of trial NCT04111510?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 6 participants. The study started on 2019-12-23. Estimated completion is 2023-05-11.

What interventions are being tested in trial NCT04111510?

The interventions under investigation include: Tumor infiltrating lymphocytes (TIL) LN-145 (DRUG).

Who is sponsoring clinical trial NCT04111510?

This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04111510's enrollment target sits among peer trials

6 1996th of 2000 higher than 1 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 NCT04111510, the US trial registry maintained by the National Library of Medicine. NCT04111510 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.