Non-small Cell Lung CancerPhase 1/2NCT04616209
Allogeneic PB103 (NK Cells) Therapy in Non-small Cell Lung Cancer (NSCLC) Patients
A Phase 1/2 study testing donor-derived NK cell infusion in people with Non-small Cell Lung Cancer, run by Precision Biotech Taiwan Corp. at 1 site in Taiwan.
Trial summary
Objectives: To determine the safety, tolerability, and efficacy of allogeneic PB103 in patients with IIIb/IV or refractory non-small-cell lung cancer Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- donor-derived NK cell infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteTaiwan
- Study dates
- 15 Nov 2020to 31 Dec 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Tri-Service General Hospital
Taipei, 11490
Min Shen Dai, MD/PhD, +886 287923311 ext. 12623, dms1201@googlemail.com
About this study
Official title: 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
Objectives: To determine the safety, tolerability, and efficacy of allogeneic PB103 in patients with IIIb/IV or refractory non-small-cell lung cancer
Read the detailed description
PB103 is allogeneic NK cells derived from a healthy donor. In this phase I/IIa trial, patients with IIIb/IV and refractory non-small cell lung cancer will be enrolled for testing the safety, tolerability, and efficacy of PB103 (NK cells). For assessment of safety and maximum tolerated dose (MTD) of PB103, three-dose levels of PB103 will be administered to enrolled patients based on the 3+3 dose-escalation design. MTD is defined as one dose level below the dose at which dose-limiting toxicities (DLT) is observed in <33% of the participants. DLT is defined as grade 4 toxicities (hematological toxicities), grade 3 toxicities (non-hematological toxicities), or acute GvHD more than grade 2. Once MTD is determined, 12 patients at MTD dose will be enrolled for assessment of safety and efficacy of PB103 at phase IIa.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- donor-derived NK cell infusion
- Keywords
- allogeneic donor, NK cells
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
donor-derived NK cell infusionBiological
PB103 administrations will be separated by 4-week interval
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Biological: donor-derived NK cell infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
safety of PB103
assessment of adverse events
Measured: one year
Secondary outcomes (1)
efficacy of PB103
assessment of Progression Free Survival, PFS
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2020
- Study start15 Nov 2020
- Primary completion30 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Precision Biotech Taiwan Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Tri-Service General Hospital (TSGH)
- Responsible party
- Sponsor
- Investigators
- Ming-Shen Dai, MD/PhD, Principal investigator, Tri-Service General Hospital (TSGH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04616209
- Sponsor's protocol ID
- PB-2020Allo
- Status last verified
- Feb 2025
- First submitted
- 8 Oct 2020
- Last updated
- 14 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04616209
- Acronym / sponsor ID
- PB-2020Allo
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- allogeneic donor, NK cells
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Precision Biotech Taiwan Corp.Industry (pharma, biotech, devices)
- Collaborators
- Tri-Service General Hospital (TSGH)
- Study start
- 15 Nov 2020 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 4 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objectives: To determine the safety, tolerability, and efficacy of allogeneic PB103 in patients with IIIb/IV or refractory non-small-cell lung cancer
Detailed description
PB103 is allogeneic NK cells derived from a healthy donor. In this phase I/IIa trial, patients with IIIb/IV and refractory non-small cell lung cancer will be enrolled for testing the safety, tolerability, and efficacy of PB103 (NK cells). For assessment of safety and maximum tolerated dose (MTD) of PB103, three-dose levels of PB103 will be administered to enrolled patients based on the 3+3 dose-escalation design. MTD is defined as one dose level below the dose at which dose-limiting toxicities (DLT) is observed in <33% of the participants. DLT is defined as grade 4 toxicities (hematological toxicities), grade 3 toxicities (non-hematological toxicities), or acute GvHD more than grade 2. Once MTD is determined, 12 patients at MTD dose will be enrolled for assessment of safety and efficacy of PB103 at phase IIa.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PB103 (donor-derived NK cells) infusion | Experimental | Biological: donor-derived NK cell infusionCohort 1: 0.5×10^9，Cohort 2:1×10^9 or Cohort 3: 1.5×10^9 cells |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| donor-derived NK cell infusionPB103 administrations will be separated by 4-week interval | Biological | PB103 (donor-derived NK cells) infusion |
Primary outcome
safety of PB103
Time frame: one year
assessment of adverse events
1 secondary outcome
efficacy of PB103
Time frame: one year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ming-Shen Dai, MD/PhD principal investigator
Tri-Service General Hospital (TSGH)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing donor-derived NK cell infusion in people with Non-small Cell Lung Cancer, run by Precision Biotech Taiwan Corp. at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chia Hua Lin, Ph.D. (+886-2-2740-0678, julielin@precisionthera.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
safety of PB103 (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2025.