Neoantigen-primed DC Vaccines Therapy for Refractory Lung Cancer

NCT03871205 | Unknown Phase 1

• 1 other identifier: ShenzhenPH BTR-001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Carcinoma, Non-Small Cell Lung; Carcinoma, Small Cell Lung

Keywords

Neoantigen; Dentritic cell vaccine; Immunotherapy; Refractory lung cancer

Outcome Measures

Primary Outcomes (2)

• Incidence of Treatment-Emergent Adverse Events [Safety]

  Safety of personalized neoantigen vaccine will be measured by the number of subjects experiencing each type of adverse event. Adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events v4.0.

  3 months after the last vaccination injection

• Immunogenicity of neoantigen-primed DC Vaccines

  Immunogenicity of the DC vaccine will be measured to detect changes of neoantigen-specific T cells by flow cytometry.

  once per three month

Secondary Outcomes (3)

• Objective Response Rate

  once per three months

• Overall Survival (OS)

  through study completion, an average of 1 year

• Progression-free Survival (PFS)

  up to 24 months after last dose of vaccine

Study Arms (1)

Vaccinated group

EXPERIMENTAL

Neoantigen loaded-DC vaccination will be performed with 6 doses in total, once per week, adjacent lymph-node injection.

Biological: Neoantigen loaded DC vaccine

Interventions

Neoantigen loaded DC vaccine BIOLOGICAL

Patients will be vaccinated with autologous mature dendritic cells loaded with neoantigen, DC vaccine will be injected subcutaneously 6 times, once a week.

Vaccinated group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shenzhen People's Hospital: lead

Study Sites (1)

Shenzhen People's Hospital

Shenzhen, Guangdong, 518020, China

Location

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Lili Ren, Ph.D.

  Shenzhen People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lili Ren, Ph.D.

CONTACT

+86-755-22942466; ren.lili@szhospital.com

Jinxing Jiang, M.D.

CONTACT

+86-755-22942466; jiang.jinxing@szhospital.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2019
• First Posted: March 12, 2019
• Study Start: April 1, 2019
• Primary Completion: June 30, 2020
• Study Completion: December 30, 2020
• Last Updated: March 12, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)