Personalized DC Vaccine for Lung Cancer (SKLB1608)

Sichuan University

Status and phase: Unknown; Phase 1

Conditions: Carcinoma, Non-Small-Cell Lung

Treatments: Biological: DC vaccine

Study type: Interventional

Funder types: Other

Identifiers

NCT02956551

SKLB1608

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

cell_therapy

Experimental group

Description:

tumor neoantigen primed DC vaccines are administrated, 2-week interval, totally 5 times

Treatment:

Biological: DC vaccine