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Non-small Cell Lung CancerPhase 1NCT07271446

An Autologous NK/CIK Cell Product (PB101) in Combination With EGFR-TKI for Treating Lung Cancer

A Phase 1 study testing PB101 plus EGFR-TKI including gefitinib, erlotinib, afatinib, or osimertinib in people with Non-small Cell Lung Cancer, run by Precision Biotech Taiwan Corp. at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This study was designed to determine the safety and tolerability of PB101 (autologous NK cell product) in combination with standard of care EGFR-TKI in patients with EGFR-mutated advanced non-small cell lung cancer. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Non-small Cell Lung Cancer
What is being tested?
PB101 plus EGFR-TKI including gefitinib, erlotinib, afatinib, or osimertinib
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
1 siteTaiwan
Study dates
1 Sep 2018to 1 Dec 2023
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
  • Acceptable organ function, as evidenced by the following laboratory data:
  • . 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)
  • . Total serum bilirubin ≤1.5 x ULN
  • . Absolute neutrophil count (ANC) ≥1500 cells/mm3
  • . Platelet count ≥75,000 cells/mm3
  • . Hgb ≥ 10.0 g/dL
  • . Serum creatinine levels ≤1.5 * ULN, or calculated (by Cockcroft-Gault formula or other accepted formula) or measure creatinine clearance ≥50 mL/min.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Tri-Service General Hospital

    Taipei, Taiwan, 114202

Other trials in Taiwan

About this study

Official title: A Phase I, Open-label Study to Evaluate Safety and Tolerability of PB101 in Combination With Standard Treatment, EGFR-TKI, in EGFR-mutated Advanced Non-small Cell Lung Cancer

This study was designed to determine the safety and tolerability of PB101 (autologous NK cell product) in combination with standard of care EGFR-TKI in patients with EGFR-mutated advanced non-small cell lung cancer.

Read the detailed description

This study will evaluate the safety of a novel autologous killer cell-based therapeutic product in patients with cancer. The trial targets patients with advanced EGFR-mutated non-small cell lung cancer (NSCLC) who continue EGFR-TKI therapy while receiving PB101-an autologous immune cell product expanded ex vivo and assessed for safety and potential efficacy. The objective is to evaluate the safety and tolerability of PB101 when administered as an adjunct autologous immune-cell therapy.

Autologous natural killer (NK) cells and natural killer T (NKT) cells possess the ability to recognize, remember, and eliminate cancer cells, as well as modulate the functions of other immune cells. Evidence from clinical applications and trials has shown that ex vivo-expanded autologous NK and NKT cells do not produce significant adverse effects and present no major safety concerns when used in cancer therapy. This study will apply our proprietary ex vivo expansion technology for autologous NK and NKT cells to clinically validate the safety and potential therapeutic activity of PB101 in patients with cancer.

This trial will enroll patients with stage III to IV lung cancer. Using our patented technology, autologous immune cells will be isolated and expanded ex vivo for approximately 15 ± 3 days to produce an NK- and NKT-enriched PB101 cell product for adjunctive clinical use. The safety of PB101 will be investigated in a cohort of six participants. Each participant will receive an intravenous infusion of 1 × 10⁹ autologous PB101 cells per dose, followed by a 2-hour post-infusion observation period before discharge. Participants will return for safety assessment 7 ± 3 days after each infusion and will subsequently receive the same dose weekly for a total of four consecutive weeks.

If any participant experiences a CTCAE v5.0 grade ≥3 adverse event during the study, safety data will be reviewed by the Data Safety Monitoring Board (DSMB), and enrollment or continuation of dose administration will proceed only after DSMB confirmation of safety. The presence or absence of adverse reactions among the six participants will determine the safety profile of the cell product and the maximum tolerated dose (MTD). A Phase II trial will be conducted based on Phase I results, expanding cohorts at a confirmed safe dose level to further evaluate clinical efficacy and therapeutic benefit.

Being tested
PB101 plus EGFR-TKI including gefitinib, erlotinib, afatinib, or osimertinib
Keywords
IIIB/IV non-small cell lung cancer, EGFR-TKI combined autologous NK/NKT Cell cell therapy
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PB101 plus EGFR-TKI including gefitinib, erlotinib, afatinib, or osimertinibBiological

    This study will be conducted in one phase. Phase I will investigate safety of PB101. Subjects will be administered 1x10^9＊cells (*allow +/-10% cell number) of PB101 over at least 30 minutes weekly for 4 weeks via intravenous infusions, 6 patients will be evaluated. Briefly, after re-visiting to the hospital in 7±3 days to confirm the safety, the subject will continue to be given 1x10^9 cells of PB101 for the following four consecutive weeks.

Study groups in NCT07271446
Study groupRoleWhat they receive
single armOtherThis study is designed as an open-label, single-arm Phase I trial to evaluate the safety and tolerability of combining EGFR-TKI therapy with PB101, an autologous NK/NKT cell product. A single-arm design is appropriate for this early-stage investigation because the enrolled patient population consists of individuals with advanced EGFR-mutated NSCLC who have limited treatment options and for whom EGFR-TKI therapy alone often results in eventual acquired resistance. The primary objective at this stage is to assess the safety of adding PB101 to ongoing standard therapy rather than to compare efficacy outcomes between treatment groups.
Receives: Biological: PB101 plus EGFR-TKI including gefitinib, erlotinib, afatinib, or osimertinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety assessment by Adverse events (AEs)

    The incidence of adverse events (AEs) was assessed by CTCAE v5.0 including the frequency and type of local toxic reactions at the injection site, including pain, lumps, erythema, granulomas, sterile cysts, and local toxic reactions judged by the clinician.

    Measured: From the beginning of the treatment to 1 year after completing 4 doses treatment

  2. Safety assessment by Severe Adverse events (SAEs)

    The incidence of severe adverse events (SAEs) was assessed by CTCAE v5.0 including the frequency and type of systemic toxic reactions, nausea, vomiting, fatigue, fever, headache, allergic reactions, uveitis, immune arthritis, and systemic toxic reactions judged by the clinician.

    Measured: From the beginning of the treatment to 1 year after completing 4 doses treatment

Secondary outcomes (3)

  1. Efficacy assessment by participants' overall response rate (ORR)

    The overall response rate (ORR) indicate that the percentage of patients in a clinical trial whose cancer has either completely disappeared or shown a significant reduction in size after treatment

    Measured: From Day -15 before treatment to 1 year after completing 4 doses cell therapy

  2. Efficacy assessment by participants' duration of response (DR)

    Secondary endpoints included duration of response (DR). Duration of Response (DoR) is a clinical trial endpoint, often used in oncology, measuring the length of time a patient's tumor continues to respond to treatment, from the onset of the response until disease progression or death.

    Measured: From Day -15 before treatment to 1 year after completing 4 doses cell therapy

  3. Efficacy assessment by participants' progression-free survival (PFS)

    Participants' progression-free survival (PFS) is the length of time that passes from the start of a clinical trial to either the disease getting worse (progression) or the participant dying.

    Measured: From Day -15 before treatment to 1 year after completing 4 doses cell therapy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Dec 2025
  2. Study start1 Sep 2018
  3. Primary completion1 Aug 2019
  4. Study completion1 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Model description
This study permit standard of care EGFR-TKIs: Gefitinib (Iressa), Erlotinib (Tarceva), Afatinib (Giotrif), or Osimertinib (Tagrisso) will be conducted in one phase. Phase I will investigate safety of PB101. Subjects will be administered 1x10\^9＊cells of PB101 over at least 30 minutes weekly for 4 weeks via intravenous infusions, 6 patients will be evaluated. Briefly, after re-visiting to the hospital in 7±3 days to confirm the safety, the subject will continue to be given 1x10\^9 cells of PB101 for the following four consecutive weeks.
Masking
None (open label)
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07271446
Sponsor's protocol ID
PB-2018-V12
Status last verified
Dec 2025
First submitted
26 Sep 2025
Last updated
9 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Zhang Q, Liu XY, Zhang T, Zhang XF, Zhao L, Long F, Liu ZK, Wang EH. The dual-functional capability of cytokine-induced killer cells and application in tumor immunology. Hum Immunol. 2015 May;76(5):385-91. doi: 10.1016/j.humimm.2014.09.021. Epub 2014 Oct 8.

    PubMed 25305457

  • Woan K, Reddy V. Potential therapeutic role of natural killer cells in cancer. Expert Opin Biol Ther. 2007 Jan;7(1):17-29. doi: 10.1517/14712598.7.1.17.

    PubMed 17150016

  • Waterhouse P, Penninger JM, Timms E, Wakeham A, Shahinian A, Lee KP, Thompson CB, Griesser H, Mak TW. Lymphoproliferative disorders with early lethality in mice deficient in Ctla-4. Science. 1995 Nov 10;270(5238):985-8. doi: 10.1126/science.270.5238.985.

    PubMed 7481803

  • Ware KE, Hinz TK, Kleczko E, Singleton KR, Marek LA, Helfrich BA, Cummings CT, Graham DK, Astling D, Tan AC, Heasley LE. A mechanism of resistance to gefitinib mediated by cellular reprogramming and the acquisition of an FGF2-FGFR1 autocrine growth loop. Oncogenesis. 2013 Mar 25;2(3):e39. doi: 10.1038/oncsis.2013.4.

    PubMed 23552882

  • Mollet TW, Garcia CA, Koester G. Skin metastases from lung cancer. Dermatol Online J. 2009 May 15;15(5):1.

    PubMed 19624979

  • Thompson CB, Allison JP. The emerging role of CTLA-4 as an immune attenuator. Immunity. 1997 Oct;7(4):445-50. doi: 10.1016/s1074-7613(00)80366-0. No abstract available.

    PubMed 9354465

  • Small EJ, Fratesi P, Reese DM, Strang G, Laus R, Peshwa MV, Valone FH. Immunotherapy of hormone-refractory prostate cancer with antigen-loaded dendritic cells. J Clin Oncol. 2000 Dec 1;18(23):3894-903. doi: 10.1200/JCO.2000.18.23.3894.

    PubMed 11099318

  • Shi SB, Tang XY, Tian J, Chang CX, Li P, Qi JL. Efficacy of erlotinib plus dendritic cells and cytokine-induced killer cells in maintenance therapy of advanced non-small cell lung cancer. J Immunother. 2014 May;37(4):250-5. doi: 10.1097/CJI.0000000000000015.

    PubMed 24714359

  • Sheng J, Fang W, Liu X, Xing S, Zhan J, Ma Y, Huang Y, Zhou N, Zhao H, Zhang L. Impact of gefitinib in early stage treatment on circulating cytokines and lymphocytes for patients with advanced non-small cell lung cancer. Onco Targets Ther. 2017 Feb 21;10:1101-1110. doi: 10.2147/OTT.S112158. eCollection 2017.

    PubMed 28260924

  • Seino K, Motohashi S, Fujisawa T, Nakayama T, Taniguchi M. Natural killer T cell-mediated antitumor immune responses and their clinical applications. Cancer Sci. 2006 Sep;97(9):807-12. doi: 10.1111/j.1349-7006.2006.00257.x. Epub 2006 Jun 29.

    PubMed 16805854

  • Segal NH, Parsons DW, Peggs KS, Velculescu V, Kinzler KW, Vogelstein B, Allison JP. Epitope landscape in breast and colorectal cancer. Cancer Res. 2008 Feb 1;68(3):889-92. doi: 10.1158/0008-5472.CAN-07-3095.

    PubMed 18245491

  • Perez VL, Van Parijs L, Biuckians A, Zheng XX, Strom TB, Abbas AK. Induction of peripheral T cell tolerance in vivo requires CTLA-4 engagement. Immunity. 1997 Apr;6(4):411-7. doi: 10.1016/s1074-7613(00)80284-8.

    PubMed 9133420

  • Parkhurst MR, Riley JP, Dudley ME, Rosenberg SA. Adoptive transfer of autologous natural killer cells leads to high levels of circulating natural killer cells but does not mediate tumor regression. Clin Cancer Res. 2011 Oct 1;17(19):6287-97. doi: 10.1158/1078-0432.CCR-11-1347. Epub 2011 Aug 15.

    PubMed 21844012

  • Ocean AJ, Vahdat LT. Chemotherapy-induced peripheral neuropathy: pathogenesis and emerging therapies. Support Care Cancer. 2004 Sep;12(9):619-25. doi: 10.1007/s00520-004-0657-7.

    PubMed 15258838

  • Niu Q, Wang W, Li Y, Qin S, Wang Y, Wan G, Guan J, Zhu W. Cord blood-derived cytokine-induced killer cells biotherapy combined with second-line chemotherapy in the treatment of advanced solid malignancies. Int Immunopharmacol. 2011 Apr;11(4):449-56. doi: 10.1016/j.intimp.2010.12.014. Epub 2011 Jan 5.

    PubMed 21215350

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PB101 plus EGFR-TKI including gefitinib, erlotinib, afatinib, or osimertinib in people with Non-small Cell Lung Cancer, run by Precision Biotech Taiwan Corp. at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety assessment by Adverse events (AEs) (time frame: From the beginning of the treatment to 1 year after completing 4 doses treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07271446, which also lists 30 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2025.

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