Back to resultsNeo-MASCT Immunotherapy for Advanced NSCLC.
Primary Purpose
NSCLC Stage IV
Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Neo-MASCT
Sponsored by
About this trial
This is an interventional treatment trial for NSCLC Stage IV
Eligibility Criteria
Inclusion Criteria:
- The age is 18 to 80 years old.
- The failure standard treatment subjects with advanced or relapsed NSCLC.
- Informed consent of the patient/legal representative was signed.
- Other anti-cancer treatments are at least one month apart from the study .
- The eastern cancer cooperative group (ECOG) was rated 0-2.
- According to the The reaction of solid tumors v1.1 (RECIST1.1 standard), there must be at least one measurable lesion .
- The baseline blood and biochemical targets met the following criteria: The hemoglobin ≧ 85g/L ;White blood cells ≧ 3.0 x10 ^ 9 / L;Platelet ≧ 50 x10 ^ 9 / L;alanine aminotransferase (ALT), serum aspartate transaminase(AST) ≦ 2.5 times normal value limit; For patients with live metastases, ALT and AST are five times the normal limit; The alkaline phosphatase(ALP) ≦ 2.5 times the normal value; Serum bilirubin less than 1.5 times the normal value limit;
Exclusion Criteria:
- Participate in the planning or implementation of the research .
- In addition to other clinical studies, unless it is an observational clinical study .
- Being pregnant or planning a pregnancy.
- Refuse to provide a blood specimen .
- Allergic to sodium hydroquinone .
- There is a history of organ transplantation
- Brain transfer of the active period
- Immunosuppressant drugs are currently in use or within 14 days prior to treatment.
- The following exceptions are:Nasal, inhaled, topical use of steroid, or topical steroids (such as interjoint injection) .
- Use a corticosteroid, no more than 10mg/day of prednisolone or its equivalent .
- The use of steroids as a preventative treatment for hypersensitivity (such as CT scans) .
Sites / Locations
- Xiaodong Jiang
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Neo-MASCT
Arm Description
Neoantigen Multiple Target Antigen Stimulating Cell Therapy ( Neo-MASCT)
Outcomes
Primary Outcome Measures
Number of participants with treatment-related adverse events as assessed by CTCAE v4.03
The incidence of treatment-related adverse events were graded with the use of the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.03
Secondary Outcome Measures
Clinical response of treatment according to RESIST v1.1 criteria
Objective Response Rate (ORR)
Disease Control Rate (DCR) based on RESIST v1.1 criteria.
Disease control rate is defined as the number of patients with a best overall response of complete response (CR), partial response (PR), or stable disease (SD).
Progression-Free Survival (PFS) based on RESIST v1.1 criteria.
The length of time from enrollment until the time of progression of disease
Overall Survival (OS) based on RESIST v1.1 criteria.
The length of time from enrollment until the time to death
Elispot report
The relationship between clinical efficacy and antigen specific immune response
Full Information
NCT ID
NCT03205930
First Posted
June 27, 2017
Last Updated
July 2, 2017
Sponsor
The First People's Hospital of Lianyungang
Collaborators
Hengrui Yuanzheng Bio-Technology Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03205930
Brief Title
Neo-MASCT Immunotherapy for Advanced NSCLC.
Official Title
A Phase I/Ⅱ Open, Single Center, One-armed Trail, Neo - MASCT Treatment for Advanced NSCLC of the Safety and Efficacy.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Unknown status
Study Start Date
August 2017 (Anticipated)
Primary Completion Date
October 2019 (Anticipated)
Study Completion Date
November 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The First People's Hospital of Lianyungang
Collaborators
Hengrui Yuanzheng Bio-Technology Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Neoantigen （Neo）is a new targets for immune cells，that the DC neoantigen immunotherapy was more effective in triggering specific T-cell responses. Neo-MASCT using the DC vaccine and neoantigen T cells .Dendritic cells(DC) was induced from autologous peripheral blood，and be loaded with antigens and re-infused. In vitro, antigen-pulsed DC can stimulate autologous T-cell proliferation and induction of autologous specific cytotoxic T-cells(CTL)，similarly re-infused.
The study is aimed to evaluate the safety of Neo-MASCT in patients with advanced NSCLC.
Detailed Description
This study is divided into two stages. The first stage is the safety study in small samples, and the second stage is the sample size expansion phase.
20 failed standard treatment patients with advanced or recurrent NSCLC will be recruited .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
NSCLC Stage IV
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Single center single arm clinical study
Masking
None (Open Label)
Masking Description
Open clinical study
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Neo-MASCT
Arm Type
Experimental
Arm Description
Neoantigen Multiple Target Antigen Stimulating Cell Therapy ( Neo-MASCT)
Intervention Type
Biological
Intervention Name(s)
Neo-MASCT
Intervention Description
The end product of Neo - MASCT technology is DC and CTL cells.DC injection,in each treatment cycle day 8, axillary, inguinal lymph node with subcutaneous injection. CTL cells， in every treatment cycle 21-28 days.
Primary Outcome Measure Information:
Title
Number of participants with treatment-related adverse events as assessed by CTCAE v4.03
Description
The incidence of treatment-related adverse events were graded with the use of the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.03
Time Frame
1 to 2 years
Secondary Outcome Measure Information:
Title
Clinical response of treatment according to RESIST v1.1 criteria
Description
Objective Response Rate (ORR)
Time Frame
1 to 2 years
Title
Disease Control Rate (DCR) based on RESIST v1.1 criteria.
Description
Disease control rate is defined as the number of patients with a best overall response of complete response (CR), partial response (PR), or stable disease (SD).
Time Frame
1 to 2 years
Title
Progression-Free Survival (PFS) based on RESIST v1.1 criteria.
Description
The length of time from enrollment until the time of progression of disease
Time Frame
From enrollment to progression of disease. Estimated about 6 months
Title
Overall Survival (OS) based on RESIST v1.1 criteria.
Description
The length of time from enrollment until the time to death
Time Frame
From enrollment to death of patients
Title
Elispot report
Description
The relationship between clinical efficacy and antigen specific immune response
Time Frame
1 to 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The age is 18 to 80 years old.
The failure standard treatment subjects with advanced or relapsed NSCLC.
Informed consent of the patient/legal representative was signed.
Other anti-cancer treatments are at least one month apart from the study .
The eastern cancer cooperative group (ECOG) was rated 0-2.
According to the The reaction of solid tumors v1.1 (RECIST1.1 standard), there must be at least one measurable lesion .
The baseline blood and biochemical targets met the following criteria: The hemoglobin ≧ 85g/L ;White blood cells ≧ 3.0 x10 ^ 9 / L;Platelet ≧ 50 x10 ^ 9 / L;alanine aminotransferase (ALT), serum aspartate transaminase(AST) ≦ 2.5 times normal value limit; For patients with live metastases, ALT and AST are five times the normal limit; The alkaline phosphatase(ALP) ≦ 2.5 times the normal value; Serum bilirubin less than 1.5 times the normal value limit;
Exclusion Criteria:
Participate in the planning or implementation of the research .
In addition to other clinical studies, unless it is an observational clinical study .
Being pregnant or planning a pregnancy.
Refuse to provide a blood specimen .
Allergic to sodium hydroquinone .
There is a history of organ transplantation
Brain transfer of the active period
Immunosuppressant drugs are currently in use or within 14 days prior to treatment.
The following exceptions are:Nasal, inhaled, topical use of steroid, or topical steroids (such as interjoint injection) .
Use a corticosteroid, no more than 10mg/day of prednisolone or its equivalent .
The use of steroids as a preventative treatment for hypersensitivity (such as CT scans) .
Facility Information:
Facility Name
Xiaodong Jiang
City
Jiangsu
State/Province
Doctor
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaodong Jiang, Doctor
Phone
+86018961326201
Email
jxdysy1970@163.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Neo-MASCT Immunotherapy for Advanced NSCLC.
We'll reach out to this number within 24 hrs