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

Carcinoma, Non-Small-Cell Lung Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03432156
• Other study ID #: BeijingFH-JW-180202-1
• Status: Recruiting
• Phase: Phase 2
• Start date: April 3, 2018
• Est. completion date: December 2020

Study information

• Verified date: December 2018
• Source: Beijing Friendship Hospital
• Contact: Jing Wang
• Phone: +86-13801334518
• Email: wj7339[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 68
• Est. completion date: December 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Be willing and able to provide written informed consent for the study.

2. Subjects with pathologically confirmed stage II NSCLC.

3. Subjects with stage II NSCLC had treatment with surgical resection and 4 cycles of postoperative adjuvant chemotherapy before the study.

4. Karnofsky (KPS) = 60.

5. 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.

6. Adequate hematologic and end-organ function.

7. Subjects who could receive treatment with at least 3 cycles of autologous Tcm cells immunotherapy.

8. Subjects must be received auxiliary examination and record these results in detail before and after immunotherapy.

9. Subjects must meet the indications for autologous Tcm cells immunotherapy.

Exclusion Criteria:

1. Subjects with lung nodules, lymph nodes, brain, liver, bone or adrenal metastasis before the study.

2. Subjects who are using immunosuppressive agents or long-term immunosuppressive agents after organ transplantation.

3. Subjects with severe abnormality of coagulation.

4. History or any evidence of hemorrhage.

5. Subjects with severe infection or high fever.

6. Subjects with severe autoimmune diseases.

7. Subjects with persistent or intractable epilepsy.

8. Subjects with merging other malignant neoplasms.

9. Subjects with mental disorder.

10. Subjects with heart, liver or kidney diseases.

11. Major surgeries except for surgical resection of NSCLC were performed in 4 weeks before the study.

12. Autologous bone marrow transplantation (ABMT) in 4 weeks before the study.

13. Concurrent treatment or treatment on another study in 4 weeks before the study.

14. Pregnancy or breast-feeding.

15. There are drug abuse, medical treatment, mental illness and social disorders that would interfere with subjects' participation, or confound the results of the trial.

16. Any condition that would interfere with or endanger the safety and compliance of subjects.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung

Intervention

Biological:
• Autologous Tcm cells immunotherapy
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.

Locations

Country	Name	City	State
China	Beijing Friendship Hospital, Capital Medical University	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Beijing Friendship Hospital	Newish Technology (Beijing) Co.,Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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) .	12 weeks
Secondary	Overall Survival (OS)	This study will evaluate the overall survival of patients after autologous Tcm cells immunotherapy according to Overall Survival (OS).	12 weeks