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Personalized DC Vaccine for Lung Cancer (SKLB1608)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02956551
Recruitment Status : Recruiting
First Posted : November 6, 2016
Last Update Posted : May 31, 2018
Sponsor:
Information provided by (Responsible Party):
Zhen-Yu Ding, Sichuan University

Brief Summary:
The study is aimed to the test the efficacy and safety of neoantigen-primed dendritic cell (DC) cell vaccine therapy for refractory non-small cell lung cancer.

Condition or disease Intervention/treatment Phase
Carcinoma, Non-Small-Cell Lung Biological: DC vaccine Phase 1

Detailed Description:
Patients with pathological confirmed non-small cell lung cancer with no standard treatment are enrolled. The patients fails in previous at least 2 lines of chemotherapy and 1 line of targeted therapy where applicable. This is a prospective exploratory trial. Patients' rebiopsy tumor tissues are subsequent to whole exosome sequencing and possible neoantigens are identified. DC is in vitro primed with synthesized peptides. Both adverse events and responses are recorded.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Neoantigen-primed DC Vaccine Therapy for Refractory Non-small Cell Lung Cancer
Actual Study Start Date : November 30, 2016
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : June 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: cell_therapy
tumor neoantigen primed DC vaccines are administrated, 2-week interval, totally 5 times
Biological: DC vaccine
subcutaneous administration




Primary Outcome Measures :
  1. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 3 months after the last administration of cells ]
    Number of participants with treatment-related adverse events as assessed by CTCAE v4.0


Secondary Outcome Measures :
  1. objective response rate [ Time Frame: through study completion, an average of 1 year ]
    Number of participants with objective responses as assayed by RECIST 1.1



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • pathologically confirmed non-small cell lung cancer
  • failed in previous standard chemotherapy and targeted therapy
  • anticipated life time > 3month
  • Karnofsky performance status 0-1
  • rehabilitate from previous therapy
  • adequate organ functions

Exclusion Criteria:

  • mixed histological types
  • tumor emergency
  • abnormal coagulation condition
  • contagious diseases, such as hepatitis B virus, hepatitis C virus, human immunodefficiency virus, tuberculosis infection
  • concomitant tumors
  • immunological co-morbidities

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02956551


Contacts
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Contact: Zhen-Yu Ding, Prof dingzhenyu@scu.edu.cn

Locations
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China, Sichuan
China West Hospital Recruiting
Chengdu, Sichuan, China, 610000
Contact: Zhen-Yu Ding, Prof    00862885423571    dingzhenyu@scu.edu.cn   
Sponsors and Collaborators
Sichuan University
Investigators
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Principal Investigator: Zhen-Yu Ding, Prof Sichuan University

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Responsible Party: Zhen-Yu Ding, Professor, Sichuan University
ClinicalTrials.gov Identifier: NCT02956551    
Other Study ID Numbers: SKLB1608
First Posted: November 6, 2016    Key Record Dates
Last Update Posted: May 31, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Zhen-Yu Ding, Sichuan University:
advanced non-small cell lung cancer
cell based therapy
safety
clinical efficacy
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Vaccines
Immunologic Factors
Physiological Effects of Drugs