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

NCT03060343 | Unknown Early Phase 1

• 1 other identifier: Z-NSCLC-01
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Non-small Cell Lung Cancer

Outcome Measures

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.

  8 weeks

Secondary Outcomes (5)

• Number of Z-CTLs in peripheral blood samples after infusion

  8 weeks

• Objective response rate (ORR)

  2 years

• Progression free survival (PFS)

  2 years

• Time to tumor progression (TTP)

  2 years

• Overall survival (OS)

  2 years

Study Arms (1)

Zeushield Cytotoxic T Lymphocytes

EXPERIMENTAL

Enrolled patients will receive Zeushield Cytotoxic T Lymphocytes by infusion

Biological: Zeushield Cytotoxic T Lymphocytes

Interventions

Zeushield Cytotoxic T Lymphocytes BIOLOGICAL

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.

Zeushield Cytotoxic T Lymphocytes

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Yu Fenglei: lead
• Hunan Zhaotai Yongren Medical Innovation Co. Ltd.: collaborator
• Hunan Yongren Medical Innovation Co. Ltd.: collaborator

Study Sites (1)

Second Xiangya Hospital of Central South University

Changsha, Hunan, 410011, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Yu Fenglei, MD, PhD

  Second Xiangya Hospital of Central South University

  PRINCIPAL INVESTIGATOR

• Li Peng, PhD

  Hunan Zhaotai Yongren Medical Innovation Co. Ltd.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Peng Muyun, MD, PhD

CONTACT

+86 18273159365; muyun880304@163.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief of the Thoracic Surgery Department

Study Record Dates

• First Submitted: February 12, 2017
• First Posted: February 23, 2017
• Study Start: November 28, 2016
• Primary Completion: November 28, 2018
• Study Completion: November 28, 2019
• Last Updated: February 23, 2017

Record last verified: 2017-02

Locations

CN (1)