Neo-MASCT Immunotherapy for Advanced NSCLC.

NCT03205930 | Unknown Phase 1

• 1 other identifier: Neo-MASCT
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

NSCLC Stage IV

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Clinical response of treatment according to RESIST v1.1 criteria

  1 to 2 years

• Disease Control Rate (DCR) based on RESIST v1.1 criteria.

  1 to 2 years

• Progression-Free Survival (PFS) based on RESIST v1.1 criteria.

  From enrollment to progression of disease. Estimated about 6 months

• Overall Survival (OS) based on RESIST v1.1 criteria.

  From enrollment to death of patients

• Elispot report

  1 to 2 years

Study Arms (1)

Neo-MASCT

EXPERIMENTAL

Neoantigen Multiple Target Antigen Stimulating Cell Therapy ( Neo-MASCT)

Biological: Neo-MASCT

Interventions

Neo-MASCT BIOLOGICAL

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.

Neo-MASCT

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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) .

Sponsors & Collaborators

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

Study Sites (1)

Xiaodong Jiang

Jiangsu, Doctor, China

Location

Related Publications (1)

• Qiao Y, Hui K, Hu C, Wang M, Sun W, Liu L, Dong C, Jiang X. Efficacy and safety of PD-1 blockade-activated neoantigen specific cellular therapy for advanced relapsed non-small cell lung cancer. Cancer Immunol Immunother. 2025 Jan 3;74(2):60. doi: 10.1007/s00262-024-03906-z.

  PMID: 39751937 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

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

Study Design

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

Model Details: Single center single arm clinical study

Study Record Dates

• First Submitted: June 27, 2017
• First Posted: July 2, 2017
• Study Start: August 1, 2017
• Primary Completion: October 1, 2019
• Study Completion: November 1, 2019
• Last Updated: July 5, 2017

Record last verified: 2017-06

Locations

CN (1)