Experimental cell therapy for resistant lung cancer tested in tiny trial
NCT ID NCT05676749
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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1 person
The number who actually took part.
- Started
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Feb 2024
- Finished
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Dec 2025
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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Allegheny Health Network-West Penn Hospital
Pittsburgh, Pennsylvania, 15224, United States
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Duke Center for Cancer Immunotherapy
Raleigh, North Carolina, 27710, United States
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Ochsner MD Anderson Cancer Center
New Orleans, Louisiana, 70121, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can radiation turn tumors into targets for immunotherapy?
- Seeing the fight: new imaging tracer may reveal how immune cells attack lung cancer
- Can a pill outperform chemo for a Hard-to-Treat lung cancer mutation?
- Can a new drug shrink Hard-to-Treat tumors?
- Breath test may reveal who benefits from lung cancer immunotherapy
- Targeted radiation and immunotherapy join forces against Hard-to-Treat lung cancer