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

NCT07271446 | Completed Phase 1 DMC

• 1 other identifier: PB-2018-V12
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Non-small Cell Lung Cancer

Keywords

IIIB/IV non-small cell lung cancer; EGFR-TKI combined autologous NK/NKT Cell cell therapy

Outcome Measures

Primary Outcomes (2)

• 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.

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

• 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.

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

Secondary Outcomes (3)

• Efficacy assessment by participants' overall response rate (ORR)

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

• Efficacy assessment by participants' duration of response (DR)

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

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

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

Study Arms (1)

single arm

OTHER

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

Interventions

PB101 plus EGFR-TKI including gefitinib, erlotinib, afatinib, or osimertinib BIOLOGICAL

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.

single arm

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Precision Biotech Taiwan Corp.: lead

Study Sites (1)

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

Taipei, Taiwan, 114202, Taiwan

Location

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MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Erlotinib Hydrochloride; Afatinib; osimertinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Amides; Organic Chemicals

Study Officials

• Kuan-Der Lee, MD PhD

  Department of Hematology and Oncology, Taipei Medical University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 26, 2025
• First Posted: December 9, 2025
• Study Start: September 1, 2018
• Primary Completion: August 1, 2019
• Study Completion: December 1, 2023
• Last Updated: December 9, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)