Back to resultsPersonalized DC Vaccine for Lung Cancer (SKLB1608)
Primary Purpose
Carcinoma, Non-Small-Cell Lung
Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
DC vaccine
Sponsored by
About this trial
This is an interventional treatment trial for Carcinoma, Non-Small-Cell Lung focused on measuring advanced non-small cell lung cancer, cell based therapy, safety, clinical efficacy
Eligibility 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
Sites / Locations
- China West HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
cell_therapy
Arm Description
tumor neoantigen primed DC vaccines are administrated, 2-week interval, totally 5 times
Outcomes
Primary Outcome Measures
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Secondary Outcome Measures
objective response rate
Number of participants with objective responses as assayed by RECIST 1.1
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02956551
Brief Title
Personalized DC Vaccine for Lung Cancer
Acronym
SKLB1608
Official Title
Neoantigen-primed DC Vaccine Therapy for Refractory Non-small Cell Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Unknown status
Study Start Date
November 30, 2016 (Actual)
Primary Completion Date
December 31, 2019 (Anticipated)
Study Completion Date
June 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sichuan University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Non-Small-Cell Lung
Keywords
advanced non-small cell lung cancer, cell based therapy, safety, clinical efficacy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
cell_therapy
Arm Type
Experimental
Arm Description
tumor neoantigen primed DC vaccines are administrated, 2-week interval, totally 5 times
Intervention Type
Biological
Intervention Name(s)
DC vaccine
Intervention Description
subcutaneous administration
Primary Outcome Measure Information:
Title
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Description
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time Frame
3 months after the last administration of cells
Secondary Outcome Measure Information:
Title
objective response rate
Description
Number of participants with objective responses as assayed by RECIST 1.1
Time Frame
through study completion, an average of 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhen-Yu Ding, Prof
Email
dingzhenyu@scu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhen-Yu Ding, Prof
Organizational Affiliation
Sichuan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
China West Hospital
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhen-Yu Ding, Prof
Phone
00862885423571
Email
dingzhenyu@scu.edu.cn
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Personalized DC Vaccine for Lung Cancer
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