Actively Recruiting

Phase 1
Phase 2
Age: 20Years - 70Years
All Genders
NCT04616209

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

Led by Precision Biotech Taiwan Corp. · Updated on 2025-02-14

24

Participants Needed

1

Research Sites

371 weeks

Total Duration

On this page

Sponsors

P

Precision Biotech Taiwan Corp.

Lead Sponsor

T

Tri-Service General Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 20Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants between 20 and 70 years of age
  • Related donor matched 6/6 at HLA-A, -B, and -DRb1 or haploidentical donor with 4/8 match at HLA-A, -B, -C, and -DRb1
  • Signed informed consent
  • Histologically or cytologically confirmed non-small-cell lung cancer stage IIIB-IV, not suitable for definitive multi-modality therapy, or recurrent disease after stage I-III diagnosis
  • Measurable or evaluable disease per RECIST v1.1
  • ECOG performance status of 0, 1, or 2
  • Life expectancy over 6 months
  • Acceptable organ function including: AST and ALT 3.0 x ULN (or 5x ULN if hepatic metastases), total bilirubin 1.5 x ULN, ANC 1500 cells/mm3, platelet count 75,000 cells/mm3, hemoglobin 9.0 g/dL, estimated GFR or creatinine clearance 60 mL/min
  • Donors between 20 and 65 years of age
  • Donors related and matched 6/6 at HLA-A, -B, and -DRb1 or haploidentical donor with 4/8 match at HLA-A, -B, -C, and -DRb1
  • Donors signed informed consent
Not Eligible

You will not qualify if you...

  • History of clinically significant interstitial lung disease or radiation pneumonitis
  • Brain metastases or leptomeningeal disease
  • Radiation to lung fields within four weeks before treatment
  • Major surgery within two weeks before treatment or not recovered from side effects; VATS or mediastinoscopy allowed after one week
  • Anti-cancer treatment toxicities not recovered to grade 0-1 except WBC and hemoglobin grade 2
  • Second clinically active cancer (inactive or treated second cancers allowed)
  • Known HIV infection
  • Receiving other investigational agents or not completed required washout
  • Receiving immunosuppressive agents or chronic corticosteroids except topical, inhaled, or local injection steroids
  • Clinically significant, uncontrolled cardiovascular disease including unstable angina, recent myocardial infarction, abnormal LVEF <50%, uncontrolled arrhythmia, or uncontrolled hypertension
  • Active infections requiring intravenous antimicrobials
  • Pregnancy or breastfeeding
  • Donors who are pregnant or breastfeeding
  • Donors with advanced tumors or autoimmune diseases
  • Donors positive for HIV, syphilis, CMV IgM, HTLV, hepatitis B or C
  • Other investigator-determined ineligibility

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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2
3
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Trial Site Locations

Total: 1 location

1

Tri-Service General Hospital

Taipei, Taiwan, 11490

Actively Recruiting

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Research Team

C

Chia Hua Lin, Ph.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

1

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