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

December 4, 2025 updated by: Precision Biotech Taiwan Corp.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
    • Taiwan
      • Taipei, Taiwan, Taiwan, 114202
        • Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Tri-Service General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: single arm
This 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.
Biological: PB101 plus EGFR-TKI including gefitinib, erlotinib, afatinib, or osimertinib
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety assessment by Adverse events (AEs)
Time Frame: From the beginning of the treatment to 1 year after completing 4 doses treatment
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.
From the beginning of the treatment to 1 year after completing 4 doses treatment
Safety assessment by Severe Adverse events (SAEs)
Time Frame: From the beginning of the treatment to 1 year after completing 4 doses treatment
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.
From the beginning of the treatment to 1 year after completing 4 doses treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy assessment by participants' overall response rate (ORR)
Time Frame: From Day -15 before treatment to 1 year after completing 4 doses cell therapy
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
From Day -15 before treatment to 1 year after completing 4 doses cell therapy
Efficacy assessment by participants' duration of response (DR)
Time Frame: From Day -15 before treatment to 1 year after completing 4 doses cell therapy
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.
From Day -15 before treatment to 1 year after completing 4 doses cell therapy
Efficacy assessment by participants' progression-free survival (PFS)
Time Frame: From Day -15 before treatment to 1 year after completing 4 doses cell therapy
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.
From Day -15 before treatment to 1 year after completing 4 doses cell therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Precision Biotech Taiwan Corp.

Investigators

  • Study Director: Kuan-Der Lee, MD PhD, Department of Hematology and Oncology, Taipei Medical University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2018

Primary Completion (Actual)

August 1, 2019

Study Completion (Actual)

December 1, 2023

Study Registration Dates

First Submitted

September 26, 2025

First Submitted That Met QC Criteria

December 4, 2025

First Posted (Estimated)

December 9, 2025

Study Record Updates

Last Update Posted (Estimated)

December 9, 2025

Last Update Submitted That Met QC Criteria

December 4, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PB-2018-V12

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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