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

NCT04616209 | Recruiting Phase 1 DMC

• 1 other identifier: PB-2020Allo
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Non-small Cell Lung Cancer

Keywords

allogeneic donor; NK cells

Outcome Measures

Primary Outcomes (1)

• safety of PB103

  assessment of adverse events

  one year

Secondary Outcomes (1)

• efficacy of PB103

  one year

Study Arms (1)

PB103 (donor-derived NK cells) infusion

EXPERIMENTAL

Cohort 1: 0.5×10\^9，Cohort 2:1×10\^9 or Cohort 3: 1.5×10\^9 cells

Biological: donor-derived NK cell infusion

Interventions

donor-derived NK cell infusion BIOLOGICAL

PB103 administrations will be separated by 4-week interval

PB103 (donor-derived NK cells) infusion

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Precision Biotech Taiwan Corp.: lead
• Tri-Service General Hospital: collaborator

Study Sites (1)

Tri-Service General Hospital

Taipei, 11490, Taiwan

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

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

Study Officials

• Ming-Shen Dai, MD/PhD

  Tri-Service General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chia Hua Lin, Ph.D.

CONTACT

+886-2-2740-0678; julielin@precisionthera.com

Study Design

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

Study Record Dates

• First Submitted: October 8, 2020
• First Posted: November 4, 2020
• Study Start: November 15, 2020
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 14, 2025

Record last verified: 2025-02

Locations

TW (1)