Precision Cell Immunotherapy Combined With Chemotherapy in Advanced Lung Cancer
NCT ID: NCT02873416
Last Updated: 2016-10-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
40 participants
INTERVENTIONAL
2016-08-31
2018-08-31
Brief Summary
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Eligibility:
Individuals greater than or equal to 18 years of age and less than or equal to 65 years of age who have been diagnosed with Advanced Lung Cancer.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Precision cells combined with Chemotherapy treatment:
Once a week with a total of six times before 60 days prior to the start of drawing blood. Precision cells：once per 3 weeks with a total of three periods.
Chemotherapy
Cisplatin：60mg/m2，Gemcitabine：1g/ m2,Physiological saline 100ml:IV (in the vein) once a week with a total of six times.
Precision Cells
Precision Cells DC cell suspension (1×10\*7 DC+physiological saline + 0.25% human bloodalbumin)1ml for each infusion, subcutaneous injection for each infusion, 3 cycles, each cycle received two infusions on day 19, 20; 40, 41; 61, 62. Precision Cell suspension (1-6×109 PNAT + physiological saline + 0.25% human bloodalbumin) 300ml for each infusion, IV (in the vein) for each infusion, 3 cycles, each cycle received one infusions on day 21, 42, 63.
Chemotherapy
Once a week with a total of six times before 60 days prior to the start of drawing blood.
Chemotherapy
Cisplatin：60mg/m2，Gemcitabine：1g/ m2,Physiological saline 100ml:IV (in the vein) once a week with a total of six times.
Interventions
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Chemotherapy
Cisplatin：60mg/m2，Gemcitabine：1g/ m2,Physiological saline 100ml:IV (in the vein) once a week with a total of six times.
Precision Cells
Precision Cells DC cell suspension (1×10\*7 DC+physiological saline + 0.25% human bloodalbumin)1ml for each infusion, subcutaneous injection for each infusion, 3 cycles, each cycle received two infusions on day 19, 20; 40, 41; 61, 62. Precision Cell suspension (1-6×109 PNAT + physiological saline + 0.25% human bloodalbumin) 300ml for each infusion, IV (in the vein) for each infusion, 3 cycles, each cycle received one infusions on day 21, 42, 63.
Eligibility Criteria
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Inclusion Criteria
2. Life expectancy≥6 months;
3. ECOG score: 0-3;
4. Advanced Malignancies (lung cancer) were diagnosed by pathological or clinical physicians;
5. Enough venous channel, no other contraindications to the separation and collection of white blood cells;
6. Laboratory examination: white blood cell≥3 x 10\*9/L, blood platelet count≥60 x10\*/L,hemoglobin≥85g/L; lymphocyte count≥15%, total bilirubin≤100 mol/L; ALT and AST less than five times of the normal level; serum creatinine less than 1.5 times of the normal level；
7. Signed informed consent；
8. Women of child-bearing age must have evidence of negative pregnancy test and be willing to practice birth control after 2 weeks following the cells transfusion.
Exclusion Criteria
2. Patients with uncontrolled hypertension (\>160/95mmHg), unstable coronary disease (uncontrolled arrhythmias, unstable angina, decompensated congestive heart failure (\> Class II, NYHA), or myocardial infarction within 6 months.
3. Other serious diseases: nervous, mental disorders, immune regulatory diseases, metabolic diseases, infectious diseases, etc;
4. Other drugs, or other biological treatment,chemotherapy or radiotherapy are performed within a month.
5. Unable or unwilling to provide informed consent, or fail to comply with the test requirements.
18 Years
65 Years
ALL
No
Sponsors
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Ningbo Cancer Hospital
INDUSTRY
Responsible Party
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Principal Investigators
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Jiangtao Wang
Role: STUDY_DIRECTOR
Ningbo No.5 Hospital (Ningbo Cancer Hospital)
Huajun Jin
Role: STUDY_CHAIR
Shanghai Cell Therapy Research Institute
Qijun Qian
Role: STUDY_CHAIR
Shanghai Cell Therapy Research Institute
Locations
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Ningbo No.5 Hospital (Ningbo Cancer Hospital)
Ningbo, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Jiangtao Wang
Role: backup
Other Identifiers
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NBWYKY2016-06-004
Identifier Type: -
Identifier Source: org_study_id
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