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Neoantigen-primed DC Vaccines Therapy for Refractory Lung Cancer

Primary Purpose

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

Status

Unknown status

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

Neoantigen loaded DC vaccine

About this trial

This is an interventional treatment trial for Carcinoma, Non-Small Cell Lung focused on measuring Neoantigen, Dentritic cell vaccine, Immunotherapy, Refractory lung cancer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Shenzhen People's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Vaccinated group

Arm Description

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

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

Objective Response Rate

The objective response rate is equal to the proportion of participants achieving a best overall response of partial response or complete response (PR + CR). Percentage of Participants Achieving a Stable Disease (SD) or a confirmed CR or PR (Disease Control Rate) Participants achieved disease control if they had a best overall response of CR, PR or SD.

Overall Survival (OS)

OS was defined as the time in months from the date of randomization to the date of death from any cause. For participants not known to have died as of the cut-off date, OS was censored at the last known date alive.

Progression-free Survival (PFS)

PFS:duration of time from start of treatment to time of progression or death, whichever occurs first.

Full Information

NCT ID

NCT03871205

First Posted

March 7, 2019

Last Updated

March 10, 2019

Sponsor

Shenzhen People's Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03871205

Brief Title

Neoantigen-primed DC Vaccines Therapy for Refractory Lung Cancer

Official Title

A Phase I Study on the Safety and the Efficacy of Personalized Neoantigen-primed Dendritic Cell Vaccines for Refractory Lung Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

February 2019

Overall Recruitment Status

Unknown status

Study Start Date

April 1, 2019 (Anticipated)

Primary Completion Date

June 30, 2020 (Anticipated)

Study Completion Date

December 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Shenzhen People's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

Neoantigen, Dentritic cell vaccine, Immunotherapy, Refractory lung cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Vaccinated group

Arm Type

Experimental

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

Neoantigen loaded DC vaccine

Intervention Description

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

Primary Outcome Measure Information:

Title

Incidence of Treatment-Emergent Adverse Events [Safety]

Description

Time Frame

3 months after the last vaccination injection

Title

Immunogenicity of neoantigen-primed DC Vaccines

Description

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

Time Frame

once per three month

Secondary Outcome Measure Information:

Title

Objective Response Rate

Description

Time Frame

once per three months

Title

Overall Survival (OS)

Description

Time Frame

through study completion, an average of 1 year

Title

Progression-free Survival (PFS)

Description

PFS:duration of time from start of treatment to time of progression or death, whichever occurs first.

Time Frame

up to 24 months after last dose of vaccine

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Lili Ren, Ph.D.

Phone

+86-755-22942466

ren.lili@szhospital.com

First Name & Middle Initial & Last Name or Official Title & Degree

Jinxing Jiang, M.D.

Phone

+86-755-22942466

jiang.jinxing@szhospital.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lili Ren, Ph.D.

Organizational Affiliation

Shenzhen People's Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Shenzhen People's Hospital

City

Shenzhen

State/Province

Guangdong

ZIP/Postal Code

518020

Country

China

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Lili Ren, Ph.D.

Phone

+86-755-22942466

ren.lili@szhospital.com

First Name & Middle Initial & Last Name & Degree

Jinxing Jiang, M.D.

Phone

+86-755-22942466

jiang.jinxing@szhospital.com

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Neoantigen-primed DC Vaccines Therapy for Refractory Lung Cancer

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