Allogeneic PB103 (NK Cells) Therapy in Non-small Cell Lung Cancer (NSCLC) Patients

Recruiting now · Phase 1/Phase 2

Conditions studied: Non-small Cell Lung Cancer

In brief

Objectives: To determine the safety, tolerability, and efficacy of allogeneic PB103 in patients with IIIb/IV or refractory non-small-cell lung cancer

Key facts

Study ID

NCT04616209

Run by

Precision Biotech Taiwan Corp.

People needed

24

Starts

2020-11-15

Expected to finish

2027-12-31

Last updated by the study team

2025-02-14

Who can join

Age: 20 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Recipient:
• Recipients (Subjects) are between 20-70 years of age.
• Related donor: 6/6 matched at HLA-A, -B and -DRb1 or haploidentical donor ≥ 4/8 match at HLA-A, -B, -C and -DRb1
• Signed informed consent.
• Subjects with histologically or cytologically confirmed non -small-cell lung cancer of stage IIIB-IV, not amenable to definitive multi-modality therapy, or recurrent disease after a prior diagnosis of stage I-III disease. All staging is determined via the American Joint Committee on Cancer (AJCC)/IASLC 8th edition proposed staging criteria.
• Subjects must have measurable or evaluable disease according to RECIST v1.1
• Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
• Lifespan over 6 months.
• Acceptable organ function, as evidenced by the following laboratory data:
• （a） Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 × upper limit of normal (ULN). (for patients with known hepatic metastases, AST and/or ALT ≤ 5× ULN) （b） Total serum bilirubin ≤ 1.5 × ULN （c） Absolute neutrophil count (ANC) ≥ 1500 cells/mm3 （d） Platelet count ≥ 75,000 cells/mm3 （e） Hgb ≥ 9.0 g/dL （f） Estimated GFR ≥ 60 ml/min /1.73m2 or creatinine clearance ≥ 60 mL/min
• Donor
• Donors are between 20-65 years of age.
• Related donor: 6/6 matched at HLA-A, -B and -DRb1 or haploidentical donor ≥ 4/8 match at HLA-A, -B, -C and -DRb1
• Signed informed consent.

You may not qualify if…

• Recipient:
• Patients with history of clinically significant interstitial lung disease or radiation pneumonitis.
• Patients with brain metastases 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 who received anti-cancer treatment and did not recover from toxicities to grades 0-1 by NCI CTCAE (version 5.0) are not eligible but WBC and Hgb Grade 2 is acceptable.
• Patients with a second, clinically active, cancer. Patients with second cancers that 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 are 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 an 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.
• Other situations the investigators think not eligible for participation in the research.
• Donor
• Donors who are pregnant and lactating women.
• Donor who has had advanced tumor diseases.
• Donor who has had autoimmune diseases.
• Donors are positive for one of human immunodeficiency virus (HIV), syphilis serology test (RPR+TPHA), CMV IgM, human T-lymphotropic virus (HTLV), and hepatitis B and C virus.
• Other situations the investigators think not eligible for participation in the research.

Where it is running

• Tri-Service General Hospital — Taipei, Taiwan (enrolling)

Full record on ClinicalTrials.gov

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