Immune cell combo shows promise in tough lung cancer
NCT ID NCT07271446
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage study tested whether adding PB101 (a patient's own natural killer cells) to standard targeted therapy is safe for people with advanced EGFR-mutated non-small cell lung cancer. Eight adults with stage IIIB/IV disease received the combination. The main goal was to check for side effects, not to prove the treatment works.
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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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8 people
The number who actually took part.
- Started
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Sep 2018
- Finished
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Dec 2023
- 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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20 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: * Men and women 20 years of age or older. * Subjects with histologically or cytologically confirmed stage IIIB/IV non-small cell lung cancer, not amenable to definitive multi-modality therapy, or recurrent disease after a prior diagnosis of stage I-III disease. All staging is via the American Joint Committee on Cancer (AJCC)/IASLC 7th edition proposed staging criteria. * EGFR sensitizing mutation must be detected in tumor tissue. Specifically, patients harboring the most common mutations, deletions in exon 19 or the L858R mutation in exon 21 are eligible. Other EGFR sensitizing mutations may be eligible after discussion with the principal investigator. * Subjects must have measurable or evaluable disease according to RECIST v1.1. * Patients may have had a prior EGFR-TKI including gefitinib, erlotinib, afatinib, or osimertinib in the metastatic setting, but treatment duration must have been less than three months at the time of enrollment. * Patients may have had no more than one prior line of chemotherapy or immunotherapy in the metastatic setting. At least 14 days must have elapsed from the last chemo/immunotherapy administration until the start of protocol treatment, and patients must have recovered from the side effects of any of these agents. * Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2. * Acceptable organ function, as evidenced by the following laboratory data: 1. . Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3.0 x upper limit of normal (ULN). (for patients with known hepatic metastases, AST and/or ALT \<5x ULN) 2. . Total serum bilirubin ≤1.5 x ULN 3. . Absolute neutrophil count (ANC) ≥1500 cells/mm3 4. . Platelet count ≥75,000 cells/mm3 5. . Hgb ≥ 10.0 g/dL 6. . Serum creatinine levels ≤1.5 \* ULN, or calculated (by Cockcroft-Gault formula or other accepted formula) or measure creatinine clearance ≥50 mL/min. Exclusion Criteria: * Patients with history of clinically significant interstitial lung disease or radiation pneumonitis. * Patients with brain metastasis or leptomeningeal disease. * Patients who have had radiation to the lung fields within four weeks of starting treatment. For all palliative radiation to all other sites, at least 7 days must have elapsed prior to starting to treatment. * Patients who have had major surgery (e.g., intra-thoracic, intra-abdominal or intra-pelvic) within two weeks prior to starting study drug or who have not recovered from side effects of such procedure. Video-assisted thoracic surgery (VATS) and mediastinoscopy will not be counted as major surgery and patients can be enrolled in the study ≥1 week after the procedure. * Patients with a second, clinically active, cancer. Patients with second cancers which have been treated with curative intent and/or are currently inactive are allowed. * Known history of human immunodeficiency virus (HIV) seropositivity. * Participants who are receiving any other investigational agents. Patients previously treated with investigational agents must complete a washout period of at least one week or five half-lives, whichever is longer, before starting treatment. * Patients receiving concomitant immunosuppressive agents or chronic corticosteroid use, except those on topical or inhaled steroids, or steroids given via local injection. * Patients with clinically significant, uncontrolled cardiovascular disease, such as: unstable angina or myocardial infarction within 6 months prior to screening, abnormal left ventricular ejection fraction (LVEF \<50%), cardiac arrhythmia not controlled with medication, uncontrolled hypertension defined as a SBP ≥ 160mm Hg and/or DBP ≥ 100mm Hg, with or without anti-hypertensive medication. Initiation or adjustment of antihypertensive medication(s) is allowed prior to screening. * Presence of fungal, bacterial, viral, or other infection requiring IV antimicrobials for management. * Pregnancy and lactating women. * Active hepatitis B or C without treatment. * Other situations the investigators think not eligible for participation in the research.
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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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Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Tri-Service General Hospital
Taipei, Taiwan, 114202, Taiwan
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Other studies related to the condition(s) this trial covers.
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