Personalized DC Vaccine for Lung Cancer

Carcinoma, Non-Small-Cell Lung Clinical Trial

— SKLB1608  

Official title:

Neoantigen-primed DC Vaccine Therapy for Refractory Non-small Cell Lung Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02956551
• Other study ID #: SKLB1608
• Status: Recruiting
• Phase: Phase 1
• Start date: November 30, 2016
• Est. completion date: June 1, 2020

Study information

• Verified date: May 2018
• Source: Sichuan University
• Contact: Zhen-Yu Ding, Prof
• Email: dingzhenyu[@]scu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: June 1, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms

Intervention

Biological:
• DC vaccine
subcutaneous administration

Locations

Country	Name	City	State
China	China West Hospital	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
Sichuan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	3 months after the last administration of cells
Secondary	objective response rate	Number of participants with objective responses as assayed by RECIST 1.1	through study completion, an average of 1 year