Personalized DC Vaccine for Lung Cancer

Phase 1

• Conditions: Carcinoma, Non-Small-Cell Lung
• Interventions: Biological: DC vaccine

• Registration Number: NCT02956551
• Lead Sponsor: 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.

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.

Study Timeline

• Study First Submitted: 2016-11-01
• Study First Submitted QC: 2016-11-03
• Study First Posted: 2016-11-06
• Study Start: 2016-11-30
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-29
• Last Update Posted: 2018-05-31
• Primary Completion: 2019-12-31
• Study Completion: 2020-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
cell_therapy	DC vaccine	tumor neoantigen primed DC vaccines are administrated, 2-week interval, totally 5 times

Primary Outcome Measures

Name	Time	Method
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	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

Name	Time	Method
objective response rate	through study completion, an average of 1 year	Number of participants with objective responses as assayed by RECIST 1.1

Trial Locations

Locations (1)

China West Hospital; 🇨🇳 Chengdu, Sichuan, China