Overview

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

Eligibility

Inclusion Criteria:

Recipient

1. Recipients (Subjects) are between 20-70 years of age.
2. Related donor: 6/6 matched at HLA-A, -B and -DRb1 or haploidentical donor ≥ 4/8 match at HLA-A, -B, -C and -DRb1
3. Signed informed consent.
4. 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.
5. Subjects must have measurable or evaluable disease according to RECIST v1.1
6. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
7. Lifespan over 6 months.
8. 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
          1. Donors are between 20-65 years of age.
          2. Related donor: 6/6 matched at HLA-A, -B and -DRb1 or haploidentical donor ≥ 4/8 match
             at HLA-A, -B, -C and -DRb1
          3. Signed informed consent.
        Exclusion Criteria:
        Recipient:
          1. Patients with history of clinically significant interstitial lung disease or radiation
             pneumonitis.
          2. Patients with brain metastases or leptomeningeal disease.
          3. 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.
          4. 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.
          5. 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.
          6. 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.
          7. Known history of human immunodeficiency virus (HIV) seropositivity.
          8. 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.
          9. Patients receiving concomitant immunosuppressive agents or chronic corticosteroid use,
             except those on topical or inhaled steroids, or steroids are given via local
             injection.
         10. 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.
         11. Presence of fungal, bacterial, viral, or other infection requiring IV antimicrobials
             for management.
         12. Pregnancy and lactating women.
         13. Other situations the investigators think not eligible for participation in the
             research.
        Donor
          1. Donors who are pregnant and lactating women.
          2. Donor who has had advanced tumor diseases.
          3. Donor who has had autoimmune diseases.
          4. 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.
          5. Other situations the investigators think not eligible for participation in the
             research.