Engineered immune cells take aim at hard-to-treat lung cancer
NCT ID NCT07641023
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new treatment using specially engineered natural killer (NK) cells to attack advanced lung cancer that has spread. About 60 adults whose tumors have certain markers will receive chemotherapy followed by an infusion of these cells. The goal is to find a safe dose and see if the cells can shrink tumors.
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 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2026
- Expected to finish
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Jun 2028
An estimate. End dates often move.
- 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 to 75 years
- 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: * Histologically or cytologically confirmed NSCLC that is unresectable Stage IIIB/IIIC or Stage IV, with radiographic progression on or after standard-of-care therapy (including platinum-based chemotherapy and immune checkpoint inhibitor when appropriate). * At least one measurable lesion per RECIST v1.1. * Archival tumor tissue available (or willingness to undergo a fresh biopsy) for antigen testing. * Tumor co-expression of at least two of the following antigens at screening: MSLN, EGFR, HER2/ERBB2. Example thresholds: IHC ≥2+ in ≥50% of tumor cells for each required antigen (or an equivalent RNA expression threshold). * ECOG performance status 0-1. * Adequate organ function (hematologic, hepatic, renal) as defined by protocol laboratory limits. * Life expectancy ≥12 weeks. * Negative pregnancy test for individuals of childbearing potential; agreement to use effective contraception for the study-defined period. * Ability to understand and willingness to sign written informed consent. Exclusion Criteria: * Active, uncontrolled central nervous system (CNS) metastases. Participants with previously treated/stable CNS disease may be eligible if clinically stable and off high-dose corticosteroids. * Prior gene-modified cellular therapy (e.g., CAR-T, CAR-NK, TCR-T) within 3 months, or any prior therapy that in the investigator's judgment increases risk of severe toxicity. * History of severe cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS) with prior therapies. * Clinically significant interstitial lung disease or pneumonitis requiring systemic steroids, or uncontrolled pulmonary comorbidity that would confound toxicity monitoring. * Active autoimmune disease requiring systemic immunosuppression (physiologic steroid replacement permitted). * Active uncontrolled infection, including uncontrolled HIV, active hepatitis B, or active hepatitis C infection. * Significant cardiovascular disease (e.g., recent myocardial infarction, unstable angina, uncontrolled arrhythmia, or LVEF below institutional lower limit). * Pregnant or breastfeeding. * Concurrent anti-cancer therapy (chemotherapy, targeted therapy, immunotherapy) within protocol-defined washout periods. * Any condition that, in the investigator's opinion, would interfere with participant safety or compliance
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Peking University Shenzhen Hospital
RECRUITINGShenzhen, Guangdong, 518036, China
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