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Autologous Tcm Cells Immunotherapy in Patients With Non-Small Cell Lung Cancer (NSCLC)

Primary Purpose

Carcinoma, Non-Small-Cell Lung

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Autologous Tcm cells immunotherapy

About this trial

This is an interventional treatment trial for Carcinoma, Non-Small-Cell Lung focused on measuring immunotherapy, NSCLC

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Be willing and able to provide written informed consent for the study.
Subjects with pathologically confirmed stage II NSCLC.
Subjects with stage II NSCLC had treatment with surgical resection and 4 cycles of postoperative adjuvant chemotherapy before the study.
Karnofsky (KPS) ≥ 60.
One or more Serum tumor markers such as carcinoembryonic antigen (CEA), CA125, cytokeratin-19 fragment (CYFRA21-1), neuron-specific enolase (NSE), pro-grp and angiopoietin-2 (Ang-2) are double higher than normal level or durative elevator on three consecutive tests.
Adequate hematologic and end-organ function.
Subjects who could receive treatment with at least 3 cycles of autologous Tcm cells immunotherapy.
Subjects must be received auxiliary examination and record these results in detail before and after immunotherapy.
Subjects must meet the indications for autologous Tcm cells immunotherapy.

Exclusion Criteria:

Subjects with lung nodules, lymph nodes, brain, liver, bone or adrenal metastasis before the study.
Subjects who are using immunosuppressive agents or long-term immunosuppressive agents after organ transplantation.
Subjects with severe abnormality of coagulation.
History or any evidence of hemorrhage.
Subjects with severe infection or high fever.
Subjects with severe autoimmune diseases.
Subjects with persistent or intractable epilepsy.
Subjects with merging other malignant neoplasms.
Subjects with mental disorder.
Subjects with heart, liver or kidney diseases.
Major surgeries except for surgical resection of NSCLC were performed in 4 weeks before the study.
Autologous bone marrow transplantation (ABMT) in 4 weeks before the study.
Concurrent treatment or treatment on another study in 4 weeks before the study.
Pregnancy or breast-feeding.
There are drug abuse, medical treatment, mental illness and social disorders that would interfere with subjects' participation, or confound the results of the trial.
Any condition that would interfere with or endanger the safety and compliance of subjects.

Sites / Locations

Beijing Friendship Hospital, Capital Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental group

No intervention group

Arm Description

subjects who are treated with autologous Tcm cells immunotherapy

subjects who are treated without autologous Tcm cells immunotherapy

Outcomes

Primary Outcome Measures

Progression-free Survival (PFS)

This study will evaluate the clinical efficacy and safety of autologous Tcm cells immunotherapy in patients with high-risk recurrent stage II NSCLC after postoperative chemotherapy according to progression-free survival (PFS) .

Secondary Outcome Measures

Overall Survival (OS)

This study will evaluate the overall survival of patients after autologous Tcm cells immunotherapy according to Overall Survival (OS).

Full Information

NCT ID

NCT03432156

First Posted

February 2, 2018

Last Updated

December 16, 2018

Sponsor

Beijing Friendship Hospital

Collaborators

Newish Technology (Beijing) Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT03432156

Brief Title

Autologous Tcm Cells Immunotherapy in Patients With Non-Small Cell Lung Cancer (NSCLC)

Official Title

Autologous Tcm Cells Immunotherapy in Patients With High-risk Recurrent Stage II Non-Small Cell Lung Cancer (NSCLC) After Postoperative Chemotherapy

Study Type

Interventional

2. Study Status

Record Verification Date

December 2018

Overall Recruitment Status

Unknown status

Study Start Date

April 3, 2018 (Actual)

Primary Completion Date

December 2019 (Anticipated)

Study Completion Date

December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Beijing Friendship Hospital

Collaborators

Newish Technology (Beijing) Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Autologous Tcm cells immunotherapy combining surgery or chemotherapy could effectively prolong survival period and improve quality of life in patients.

Detailed Description

Autologous central memory T cells (Tcm) cells immunotherapy is to collect patient's own immune cells in peripheral blood and then given back to the patient after amplified in vitro that can improve the anti-tumor immune response and is effective treatment of the cancer. Tcm cells are effective anti-tumor immune cells that exhibit the long-term survival and self-renewal capacity in vivo. Autologous Tcm cells immunotherapy combining surgery or chemotherapy could effectively prolong survival period and improve quality of life in patients. Lung cancer is the leading cause of cancer related deaths, which account for one third of all deaths due to cancer worldwide. The most common histologic type of lung cancer is non-small-cell lung cancer (NSCLC) that is accounting for almost 85%. There are no targeted therapeutics in patients with high-risk recurrent stage II NSCLC after postoperative chemotherapy, therefore, autologous Tcm cells immunotherapy would be a safe and effective treatment. The aim of this study is to assess the efficacy and safety of autologous Tcm cells immunotherapy in patients with high-risk recurrent stage II NSCLC after postoperative chemotherapy. Patients will be randomized 1:1 either to the experimental arm to receive 3 cycles of autologous Tcm cells immunotherapy or to the no intervention arm.

6. Conditions and Keywords

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

Carcinoma, Non-Small-Cell Lung

Keywords

immunotherapy, NSCLC

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Model Description

Experimental group: immunotherapy. subjects who are treated with autologous Tcm cells immunotherapy. No intervention group: subjects who are treated without autologous Tcm cells immunotherapy.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

68 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Experimental group

Arm Type

Experimental

Arm Description

subjects who are treated with autologous Tcm cells immunotherapy

Arm Title

No intervention group

Arm Type

No Intervention

Arm Description

subjects who are treated without autologous Tcm cells immunotherapy

Intervention Type

Biological

Intervention Name(s)

Autologous Tcm cells immunotherapy

Intervention Description

Autologous Tcm cells immunotherapy is to collect patient's own immune cells in peripheral blood and then given back to the patient after amplified in vitro.

Primary Outcome Measure Information:

Title

Progression-free Survival (PFS)

Description

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Overall Survival (OS)

Description

This study will evaluate the overall survival of patients after autologous Tcm cells immunotherapy according to Overall Survival (OS).

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Be willing and able to provide written informed consent for the study. Subjects with pathologically confirmed stage II NSCLC. Subjects with stage II NSCLC had treatment with surgical resection and 4 cycles of postoperative adjuvant chemotherapy before the study. Karnofsky (KPS) ≥ 60. One or more Serum tumor markers such as carcinoembryonic antigen (CEA), CA125, cytokeratin-19 fragment (CYFRA21-1), neuron-specific enolase (NSE), pro-grp and angiopoietin-2 (Ang-2) are double higher than normal level or durative elevator on three consecutive tests. Adequate hematologic and end-organ function. Subjects who could receive treatment with at least 3 cycles of autologous Tcm cells immunotherapy. Subjects must be received auxiliary examination and record these results in detail before and after immunotherapy. Subjects must meet the indications for autologous Tcm cells immunotherapy. Exclusion Criteria: Subjects with lung nodules, lymph nodes, brain, liver, bone or adrenal metastasis before the study. Subjects who are using immunosuppressive agents or long-term immunosuppressive agents after organ transplantation. Subjects with severe abnormality of coagulation. History or any evidence of hemorrhage. Subjects with severe infection or high fever. Subjects with severe autoimmune diseases. Subjects with persistent or intractable epilepsy. Subjects with merging other malignant neoplasms. Subjects with mental disorder. Subjects with heart, liver or kidney diseases. Major surgeries except for surgical resection of NSCLC were performed in 4 weeks before the study. Autologous bone marrow transplantation (ABMT) in 4 weeks before the study. Concurrent treatment or treatment on another study in 4 weeks before the study. Pregnancy or breast-feeding. There are drug abuse, medical treatment, mental illness and social disorders that would interfere with subjects' participation, or confound the results of the trial. Any condition that would interfere with or endanger the safety and compliance of subjects.

Central Contact Person:

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

Jing Wang

Phone

+86-13801334518

wj7339@sina.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jing Wang

Organizational Affiliation

Beijing Friendship Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Beijing Friendship Hospital, Capital Medical University

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100050

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jing Wang

Phone

+86-13801334518

wj7339@sina.com

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Autologous Tcm Cells Immunotherapy in Patients With Non-Small Cell Lung Cancer (NSCLC)

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