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

NCT03060343 · Status: UNKNOWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2017-02-23

No results posted yet for this 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.

Conditions

Interventions

BIOLOGICAL

Zeushield 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.

Sponsors & Collaborators

  • Hunan Zhaotai Yongren Medical Innovation Co. Ltd.

    collaborator OTHER

  • Hunan Yongren Medical Innovation Co. Ltd.

    collaborator UNKNOWN

  • Yu Fenglei

    lead OTHER

Principal Investigators

  • Yu Fenglei, MD, PhD · Second Xiangya Hospital of Central South University

  • Li Peng, PhD · Hunan Zhaotai Yongren Medical Innovation Co. Ltd.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-28
Primary Completion
2018-11-28
Completion
2019-11-28

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03060343 on ClinicalTrials.gov