Status:
UNKNOWN
Autologous Tcm Cells Immunotherapy in Patients With Non-Small Cell Lung Cancer (NSCLC)
Lead Sponsor:
Beijing Friendship Hospital
Collaborating Sponsors:
Newish Technology (Beijing) Co., Ltd.
Conditions:
Carcinoma, Non-Small-Cell Lung
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
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 th...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 3 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2020
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT03432156
Start Date
April 3 2018
End Date
December 1 2020
Last Update
December 19 2018
Active Locations (1)
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1
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100050