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Status unknownNCT03060343Updated Feb 23, 2017

Zeushield Cytotoxic T Lymphocytes (Z-CTLs) for Relapsed or Refractory Non Small Cell Lung Cancer (NSCLC)

An Early Phase 1 interventional study of Zeushield Cytotoxic T Lymphocytes in Non-small Cell Lung Cancer, sponsored by Yu Fenglei. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-02-23.

Sponsored by Yu Fenglei · Early Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2017), so the status shown — last known as Recruiting — may be out of date.
Phase
Early Phase 1
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study 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 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).

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Conditions studied

  • Non-small Cell Lung Cancer
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In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's planned enrollment of 10 is below the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

This is the only study on the registry with Yu Fenglei as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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
  • 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;

Exclusion criteria

Exclusion Criteria:

  • 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)
  • 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
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Study design

Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (estimated)

Study arms

  • Experimental
    Zeushield Cytotoxic T Lymphocytes

    Enrolled patients will receive Zeushield Cytotoxic T Lymphocytes by infusion

    Biological: Zeushield Cytotoxic T Lymphocytes

Interventions

  • BiologicalZeushield Cytotoxic T Lymphocytes

    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.

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 8 weeks

Secondary outcomes

  1. Number of Z-CTLs in peripheral blood samples after infusion

    Detect Z-CTLs in peripheral blood samples after infusion by flow cytometry every week

    Time frame: 8 weeks

  2. Objective response rate (ORR)

    the ratio of patients diagnosed as partial remission (PR) to complete remission (CR) according to RECIST 1.1 criteria

    Time frame: 2 years

  3. Progression free survival (PFS)

    the duration from baseline to PD (audited and confirmed by independent imaging), or to the day of any death event

    Time frame: 2 years

  4. Time to tumor progression (TTP)

    the duration from baseline to disease starts to get worse or spreads to other parts of the body

    Time frame: 2 years

  5. 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

    Time frame: 2 years

07

Study locations

1 of 1 sites recruiting
  • Second Xiangya Hospital of Central South University
    Changsha, Hunan 410011, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 23, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03060343
Lead sponsor
Yu Fenglei
Collaborators
Hunan Zhaotai Yongren Medical Innovation Co. Ltd., Hunan Yongren Medical Innovation Co. Ltd.
Responsible party
Yu Fenglei (Chief of the Thoracic Surgery Department, Second Xiangya Hospital of Central South University) — Sponsor-investigator
First posted
Feb 23, 2017
Start date
Nov 28, 2016
Primary completion
Nov 28, 2018 (estimated)
Completion
Nov 28, 2019 (estimated)
Last update
Feb 23, 2017

Study contacts

Peng Muyun, MD, PhD
Contact
muyun880304@163.com
+86 18273159365
Yu Fenglei, MD, PhD
principal investigator · Central South University
Li Peng, PhD
principal investigator · Hunan Zhaotai Yongren Medical Innovation Co. Ltd.

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.

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