Neo-MASCT Immunotherapy for Advanced NSCLC.

A Phase I/Ⅱ Open, Single Center, One-armed Trail, Neo - MASCT Treatment for Advanced NSCLC of the Safety and Efficacy.

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.

Study Overview

• Status: Unknown
• Conditions: NSCLC Stage IV
• Intervention / Treatment: Biological: Neo-MASCT

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 .

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Doctor
    • Jiangsu, Doctor, China
      • Xiaodong Jiang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. The age is 18 to 80 years old.
2. The failure standard treatment subjects with advanced or relapsed NSCLC.
3. Informed consent of the patient/legal representative was signed.
4. Other anti-cancer treatments are at least one month apart from the study .
5. The eastern cancer cooperative group (ECOG) was rated 0-2.
6. According to the The reaction of solid tumors v1.1 (RECIST1.1 standard), there must be at least one measurable lesion .
7. 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:

1. Participate in the planning or implementation of the research .
2. In addition to other clinical studies, unless it is an observational clinical study .
3. Being pregnant or planning a pregnancy.
4. Refuse to provide a blood specimen .
5. Allergic to sodium hydroquinone .
6. There is a history of organ transplantation
7. Brain transfer of the active period
8. Immunosuppressant drugs are currently in use or within 14 days prior to treatment.
9. The following exceptions are:Nasal, inhaled, topical use of steroid, or topical steroids (such as interjoint injection) .
10. Use a corticosteroid, no more than 10mg/day of prednisolone or its equivalent .
11. The use of steroids as a preventative treatment for hypersensitivity (such as CT scans) .

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Neo-MASCT; Neoantigen Multiple Target Antigen Stimulating Cell Therapy ( Neo-MASCT)	Biological: Neo-MASCT; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	1 to 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical response of treatment according to RESIST v1.1 criteria	Objective Response Rate (ORR)	1 to 2 years
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).	1 to 2 years
Progression-Free Survival (PFS) based on RESIST v1.1 criteria.	The length of time from enrollment until the time of progression of disease	From enrollment to progression of disease. Estimated about 6 months
Overall Survival (OS) based on RESIST v1.1 criteria.	The length of time from enrollment until the time to death	From enrollment to death of patients
Elispot report	The relationship between clinical efficacy and antigen specific immune response	1 to 2 years

Collaborators and Investigators

• Sponsor: The First People's Hospital of Lianyungang
• Collaborators: Hengrui Yuanzheng Bio-Technology Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2017
• Primary Completion (Anticipated): October 1, 2019
• Study Completion (Anticipated): November 1, 2019

Study Registration Dates

• First Submitted: June 27, 2017
• First Submitted That Met QC Criteria: June 29, 2017
• First Posted (Actual): July 2, 2017

Study Record Updates

• Last Update Posted (Actual): July 5, 2017
• Last Update Submitted That Met QC Criteria: July 2, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: Neo-MASCT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No