Non-small Cell Lung CancerEarly Phase 1NCT03060343
Zeushield Cytotoxic T Lymphocytes (Z-CTLs) for Relapsed or Refractory Non Small Cell Lung Cancer (NSCLC)
A Early Phase 1 study testing Zeushield Cytotoxic T Lymphocytes in people with Non-small Cell Lung Cancer, run by Yu Fenglei at 1 site in China.
Trial summary
A single-center, open-label pilot study to determine the safety, tolerance and engraftment potential of zeushield cytotoxic T lymphocytes in subjects with PD-L1+ positive non-small cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- Zeushield Cytotoxic T Lymphocytes
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 28 Nov 2016to 28 Nov 2019
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or women aged >18 years old
- Subjects are diagnosed as refractory, recurrent ,metastatic, advanced non-small cell lung cancer by histological and cytological methods including specific lesion-targeted brush biopsy, lavage and fine needle aspiration;
- Have at least one new measurable tumor lesion compared with previous irradiated region
- Tumor tissues samples confirmed as PD-L1 positive
- Expected survival≥12 weeks
- ECOG scored as 0-1 or KPS grading > 80
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- PLT≥100000/mm3
- Hb≥9.0g/dL
- Serum creatinine≤2.5mg/dL，CCR≥50ml/min (renal malfunction defined as CCR<50ml/min according to Cockroft-Gault formula)
- ALT and AST≤2.5ULN; for liver metastasis，ALT and AST ≤5ULN
- Serum TBiL≤3.0mg/dL, TBiL≤2.5ULN
- PT: INR < 1.7 or extended PT to normal value < 4s
- Adequate venous access for apheresis or venous blood collection, and no other contraindication of blood cell separation
- Patients with willingness to be in this study and able to provide informed consent
- Capable of receiving treatment and follow up, included subjects are required to receive treatment in the enrolled centre
- Women of childbearing age are required to take acceptable measures to minimize the possibility of pregnancy during whole session. Women of childbearing age must have negative results of serum or urine tests within 24 hours prior to infusion. Women subjects must not be in lactation;
Who cannot join
- pregnant women or women in lactation
- active HBV or HCV infection
- HIV/AIDS infection
- active infection
- previously suffered from diseases or concurrent diseases as followed：
- patients confirmed as severe autoimmune diseases in long-term (over 2 months) need of systemic immune inhibitors (steroid) or as immune-mediated symptomatic diseases including ulcerative colitis, Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus (SLE), autoimmune vasculitis (for example, Wegener's granulomatosis)
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- subjects with previous diagnosis as motor neurone disease caused by autoimmunity
- subjects previously suffered from toxic epidermal necrolysis (TEN)
- subjects with any mental diseases including dementia, mental status change that may impinge the understanding and performance of informed consent and related questionnaire
- subjects with severe, uncontrollable diseases judged by investigators that may hinder them receiving this treatment
- subjects with previously active malignant tumors including basal or squamous skin cancer, superficial bladder cancer, and in situ breast carcinoma within 5 years who had been completely cured without the need of follow-up treatment are not excluded.
- during ongoing treatment using systemic steroid or steroid inhalants
- subjects with unstable or active peptic ulcer or alimentary tract hemorrhage
- subjects with previous organ transplantation or ready for organ transplantation
- subjects in need of anticoagulant therapy treatment (warfarin or heparin)
- subjects judged by investigators as not appropriate for this study
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Second Xiangya Hospital of Central South University
Changsha, Hunan, 410011
Peng Muyun, MD, +86 18273159365, muyun880304@163.com
About this study
Official title: Preliminary Clinical Study of Autologous T Cells Modified Chimeric Antigen Receptor (CAR) Targeting PD-L1 and CD80/CD86 (Zeushield Cytotoxic T Lymphocytes) for the Treatment of Recurrent or Refractory Non Small Cell Lung Cancer
A single-center, open-label pilot study to determine the safety, tolerance and engraftment potential of zeushield cytotoxic T lymphocytes in subjects with PD-L1+ positive non-small cell lung cancer.
Read the detailed description
The purpose of this first in human study is to determine the safety and feasibility of Zeushield Cytotoxic T Lymphocytes(Z-CTLs) in patients with relapsed or refractory NSCLC. Z-CTLs therapy is a novel immunotherapy under investigation in which patients have their T-cells (a type of white blood cell) collected and modified in the laboratory, before they are given back to the patient. The T-cells are modified to transform the intracellular signal domain of PD-1 and CTLA-4 to immune activation stimulus signal and transform T cells to a new kind of cancer-killer cells: zeushield cytotoxic T lymphocytes (Z-CTls).
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- Zeushield Cytotoxic T Lymphocytes
- 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.
Zeushield Cytotoxic T LymphocytesBiological
Three dose levels will be evaluated. Dose Level One: 1.0×10^5 cells/kg, Dose Level Two: 1.0×10^6 cells/kg, Dose Level Three: 1.0×10^7 cells/kg.
At the discretion of the investigator, if patients with active disease have stable disease or a response at week 8 or on subsequent evaluations, they are eligible to receive up to 6 additional infusions at 8 to 12 week intervals.
| Study group | Role | What they receive |
|---|---|---|
| Zeushield Cytotoxic T Lymphocytes | Experimental | Enrolled patients will receive Zeushield Cytotoxic T Lymphocytes by infusion Receives: Biological: Zeushield Cytotoxic T Lymphocytes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Observe and determine the potential adverse events related to the escalating dose infusion of Z-CTLs such as high fever,jaundice, kidney failure and so on.
Measured: 8 weeks
Secondary outcomes (5)
Number of Z-CTLs in peripheral blood samples after infusion
Detect Z-CTLs in peripheral blood samples after infusion by flow cytometry every week
Measured: 8 weeks
Objective response rate (ORR)
the ratio of patients diagnosed as partial remission (PR) to complete remission (CR) according to RECIST 1.1 criteria
Measured: 2 years
Progression free survival (PFS)
the duration from baseline to PD (audited and confirmed by independent imaging), or to the day of any death event
Measured: 2 years
Time to tumor progression (TTP)
the duration from baseline to disease starts to get worse or spreads to other parts of the body
Measured: 2 years
Overall survival (OS)
the time period from the 1st day of treatment to the day of death for any reason. For patients who are still alive at the data analysis day, OS data is subject to the last confirmed time of survival patients
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start28 Nov 2016
- Primary completion28 Nov 2018 (estimated)
- Study completion28 Nov 2019 (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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yu Fenglei
- Sponsor type
- University, hospital or other
- Collaborators
- Hunan Zhaotai Yongren Medical Innovation Co. Ltd., Hunan Yongren Medical Innovation Co. Ltd.
- Responsible party
- Sponsor-investigator, Yu Fenglei, Second Xiangya Hospital of Central South University
- Investigators
- Yu Fenglei, MD, PhD, Principal investigator, Second Xiangya Hospital of Central South UniversityLi Peng, PhD, Principal investigator, Hunan Zhaotai Yongren Medical Innovation Co. Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03060343
- Sponsor's protocol ID
- Z-NSCLC-01
- Status last verified
- Feb 2017
- First submitted
- 12 Feb 2017
- Last updated
- 23 Feb 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preliminary Clinical Study of Autologous T Cells Modified Chimeric Antigen Receptor (CAR) Targeting PD-L1 and CD80/CD86 (Zeushield Cytotoxic T Lymphocytes) for the Treatment of Recurrent or Refractory Non Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT03060343
- Acronym / sponsor ID
- Z-NSCLC-01
- Conditions
- Non-small Cell Lung Cancer
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Yu FengleiUniversity, hospital or other
- Collaborators
- Hunan Zhaotai Yongren Medical Innovation Co. Ltd., Hunan Yongren Medical Innovation Co. Ltd.
- Study start
- 28 Nov 2016 (actual)
- Primary completion
- 28 Nov 2018 (estimated)
- Study completion
- 28 Nov 2019 (estimated)
- First posted
- 23 Feb 2017 (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.
A single-center, open-label pilot study to determine the safety, tolerance and engraftment potential of zeushield cytotoxic T lymphocytes in subjects with PD-L1+ positive non-small cell lung cancer.
Detailed description
The purpose of this first in human study is to determine the safety and feasibility of Zeushield Cytotoxic T Lymphocytes(Z-CTLs) in patients with relapsed or refractory NSCLC. Z-CTLs therapy is a novel immunotherapy under investigation in which patients have their T-cells (a type of white blood cell) collected and modified in the laboratory, before they are given back to the patient. The T-cells are modified to transform the intracellular signal domain of PD-1 and CTLA-4 to immune activation stimulus signal and transform T cells to a new kind of cancer-killer cells: zeushield cytotoxic T lymphocytes (Z-CTls).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Zeushield Cytotoxic T Lymphocytes | Experimental | Biological: Zeushield Cytotoxic T LymphocytesEnrolled patients will receive Zeushield Cytotoxic T Lymphocytes by infusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Men or women aged >18 years old
- Subjects are diagnosed as refractory, recurrent ,metastatic, advanced non-small cell lung cancer by histological and cytological methods including specific lesion-targeted brush biopsy, lavage and fine needle aspiration;
- Have at least one new measurable tumor lesion compared with previous irradiated region
- Tumor tissues samples confirmed as PD-L1 positive
- Expected survival≥12 weeks
Key exclusion criteria (16 listed)
- pregnant women or women in lactation
- active HBV or HCV infection
- HIV/AIDS infection
- active infection
- previously suffered from diseases or concurrent diseases as followed：
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 |
|---|---|---|
| Zeushield Cytotoxic T LymphocytesThree dose levels will be evaluated. Dose Level One: 1.0×10^5 cells/kg, Dose Level Two: 1.0×10^6 cells/kg, Dose Level Three: 1.0×10^7 cells/kg. At the discretion of the investigator, if patients with active disease have stable disease or a response at week 8 or on subsequent evaluations, they are eligible to receive up to 6 additional infusions at 8 to 12 week intervals. | Biological | Zeushield Cytotoxic T Lymphocytes |
Primary outcome
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 8 weeks
Observe and determine the potential adverse events related to the escalating dose infusion of Z-CTLs such as high fever,jaundice, kidney failure and so on.
5 secondary outcomes
Number of Z-CTLs in peripheral blood samples after infusion
Time frame: 8 weeks
Objective response rate (ORR)
Time frame: 2 years
Progression free survival (PFS)
Time frame: 2 years
Time to tumor progression (TTP)
Time frame: 2 years
Overall survival (OS)
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2017.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Yu Fenglei, MD, PhD principal investigator
Second Xiangya Hospital of Central South University
Li Peng, PhD principal investigator
Hunan Zhaotai Yongren Medical Innovation Co. Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Zeushield Cytotoxic T Lymphocytes in people with Non-small Cell Lung Cancer, run by Yu Fenglei at 1 site in China.
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 16 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 23 Feb 2017. 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 China. 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 phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Peng Muyun, MD, PhD (+86 18273159365, muyun880304@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 (time frame: 8 weeks). 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 23 Feb 2017.