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Experimental cell therapy for resistant lung cancer tested in tiny trial

NCT ID NCT05676749

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-phase trial tested a new treatment called C-TIL051 for people with advanced non-small cell lung cancer that no longer responded to standard immunotherapy. The treatment involved taking immune cells from the patient's tumor, growing them in a lab, and infusing them back along with two other drugs to boost their activity. Only one person was enrolled before the study was terminated, so we have very limited information on safety or effectiveness.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
C-TIL051 (tumor-infiltrating lymphocytes) combined with NKTR-255 (IL-15) and pembrolizumab
What this could lead to
If it works, this could point toward a new treatment option for people with lung cancer that stopped responding to standard immunotherapy.
What could go wrong
This was a very early, small phase 1 trial that was terminated after only one participant. The approach is complex and risky, involving chemotherapy and multiple drugs, and may not prove effective or safe in larger studies.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

1 person

The number who actually took part.

Started

Feb 2024

Finished

Dec 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Able to understand and give written informed consent * Histologically and cytologically confirmed diagnosis of stage IV or recurrent non-small cell lung cancer (NSCLC) with adenocarcinoma or squamous histology * Planned for treatment with an anti-PD1 agent * Tumor accessible by surgery, previously not irradiated and ≥ 1.5 cm in diameter * Measurable disease after resection of tumor by RECIST 1.1 * ECOG ≤ 1 * Expected survival \> 6 months * Adequate organ and marrow function * ECHO, MUGA or cardiac stress test within past 6 months showing LVEF \>50% and without evidence of reversible ischemia * Pulmonary function tests within past 6 months showing DLCO \>50% of predicted Exclusion Criteria: * Previous treatment with PD1/PDL1 inhibitor for metastatic disease, Immune checkpoint blockade (ICB) given as part of definitive therapy for stage Ib-III disease with surgery or after chemo/radiation is acceptable if last dose of ICB is at least 6 months prior to enrollment in this study. * Known driver mutations such as EGFR, ALK, ROS1, RET, METex14, and NTRK alterations. * Current or prior use of any immunosuppressive medications within 14 days before tumor harvest * Known active CNS metastases which are symptomatic * History of leptomeningeal metastases * Uncontrolled intercurrent illness * Known history of HIV+ or AIDS, hepatitis C, acute or chronic active hepatitis B or other serious chronic infection * Live vaccine within 30 days of tumor harvest * History of allogeneic organ transplant * History of primary immunodeficiency * Hypersensitivity to anti-PD1 agent, cyclophosphamide, fludarabine, interleukin-2, gentamicin, or any excipient * Any condition that may interfere with evaluation of study treatment, safety or study results * Active infection that requires IV antibiotics within 7 days of tumor harvest * Unresolved greater than grade 1 toxicity (CTCAE v5.0) from previous therapy * History of interstitial pneumonitis of autoimmune etiology that is symptomatic or requires treatment * Pulmonary disease history requiring escalating amounts of oxygen \> 2L * Known autoimmune conditions requiring systemic immune suppression therapy other than low dose prednisone or equivalent. * Other malignancy, other than cutaneous localized) that required active treatment in the last 2 years. * Women who are pregnant or lactating * Women of childbearing potential or fertile men who are unwilling to use effective contraception during study and 6 months after treatment

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Allegheny Health Network-West Penn Hospital

    Pittsburgh, Pennsylvania, 15224, United States

  • Duke Center for Cancer Immunotherapy

    Raleigh, North Carolina, 27710, United States

  • Ochsner MD Anderson Cancer Center

    New Orleans, Louisiana, 70121, United States

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