Neoantigen-primed DC Vaccines Therapy for Refractory Lung Cancer

Southern University of Science and Technology

Status and phase

Unknown

Phase 1

Conditions

Carcinoma, Non-Small Cell Lung

Carcinoma, Small Cell Lung

Treatments

Biological: Neoantigen loaded DC vaccine

Study type

Interventional

Funder types

Other

Identifiers

NCT03871205

ShenzhenPH BTR-001

Details and patient eligibility

About

Various of immunotherapies are now widely applied in the treatment of lung cancer. Neoantigens arising from the mutations of the tumor genome expressed specifically on the tumor cell instead of normal cells, suggesting that vaccines targeting neoantigens should generate a highly tumor-specific response with minimal off-target effects. Neoantigens are highly suitable for the development of cancer vaccines. The study aims to evaluate the safety and efficacy of neoantigen-loaded dendritic cell (DC) vaccines for refractory lung cancer.

Full description

Cancer genome research has exploded benefits from the application of modern high-throughput genome sequencing in the past few years. Since usually there are no common antigens expressed on the surfaces of different kinds of tumors, neoantigens which expressed specifically in the individual tumor are chosen to establish tumor-specific vaccines.

30 patients with refractory lung cancer would be enrolled and undergo tumor resection if all requirements are met. The whole-exome sequencing and the bioinformatic analysis of the resected specimens would be performed to identify the neoantigens. Then, candidate neoantigens would be synthesized to pulse the matured DC cells. Neoantigen-primed DC vaccines are provided to the corresponding patients. Each patient would be vaccinated 6 times in total, one shot per week.

Patients enrolled would undergo the schemed follow-up, one time per three months. The side effects, overall survival, and progress-free survival would be recorded. At the end of the research, the safety and efficacy of neoantigen DC vaccines for refractory lung cancer would be evaluated.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age ≥18 years ≤ 70 years at the time of informed consent
Signed informed consent to be provided
pathologically confirmed lung cancer
failed in previous standard chemotherapy and targeted therapy
Life expectancy not less than 90 days
Karnofsky performance status 0-1
adequate organ functions

Exclusion criteria

Actively infectious condition including hepatitis
Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the treatment on the fetus or infant.
Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease).
Concurrent opportunistic infections (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who have decreased immune competence may be less responsive to the experimental treatment and more susceptible to its toxicities).
Active systemic infections, coagulation disorders or any other active major medical illnesses.
Patients who are receiving any other investigational agents.