- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04616209
Allogeneic PB103 (NK Cells) Therapy in Non-small Cell Lung Cancer (NSCLC) Patients
A Phase Ι & IIa, Open-label Study to Evaluate Safety and Efficacy of the Combination Therapy of Allogeneic PB103 and Standard Cancer Treatment in the IIIB/IV or Recurrent Non-small Cell Lung Cancer (NSCLC) Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Contact
- Name: Chia Hua Lin, Ph.D.
- Phone Number: +886-2-2740-0678
- Email: julielin@precisionthera.com
Study Contact Backup
- Name: Yen Wen Huang, Ph.D.
- Phone Number: +886-2-2740-0678
- Email: phihuang@precisionthera.com
Study Locations
-
-
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Taipei city, Taiwan, 11490
- Recruiting
- Tri-Service General Hospital
-
Contact:
- Min Shen Dai, MD/PhD
- Phone Number: 12623 +886 287923311
- Email: dms1201@googlemail.com
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: PB103 (donor-derived NK cells) infusion
Cohort 1: 0.5×10^9,Cohort 2:1×10^9 or Cohort 3: 1.5×10^9 cells
|
PB103 administrations will be separated by 4-week interval
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
safety of PB103
Time Frame: one year
|
assessment of adverse events
|
one year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
efficacy of PB103
Time Frame: one year
|
assessment of Progression Free Survival, PFS
|
one year
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Ming-Shen Dai, MD/PhD, Tri-Service General Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PB-2020Allo
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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