Neoantigen-primed DC Vaccines Therapy for Refractory Lung Cancer
NCT ID: NCT03871205
Last Updated: 2019-03-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
30 participants
INTERVENTIONAL
2019-04-01
2020-12-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Vaccinated group
Neoantigen loaded-DC vaccination will be performed with 6 doses in total, once per week, adjacent lymph-node injection.
Neoantigen loaded DC vaccine
Patients will be vaccinated with autologous mature dendritic cells loaded with neoantigen, DC vaccine will be injected subcutaneously 6 times, once a week.
Interventions
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Neoantigen loaded DC vaccine
Patients will be vaccinated with autologous mature dendritic cells loaded with neoantigen, DC vaccine will be injected subcutaneously 6 times, once a week.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
70 Years
ALL
No
Sponsors
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Shenzhen People's Hospital
OTHER
Responsible Party
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Principal Investigators
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Lili Ren, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Shenzhen People's Hospital
Locations
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Shenzhen People's Hospital
Shenzhen, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ShenzhenPH BTR-001
Identifier Type: -
Identifier Source: org_study_id
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