Trial | NCT02873416  Report issue

Title

Precision Cell Immunotherapy Combined With Chemotherapy in Advanced Lung Cancer
Clinical Study Using Precision Cell Immunotherapy Combined With Chemotherapy in Advanced Lung Cancer

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    40
To evaluate the safety and effectiveness of cell therapy using Precision Cell Immunotherapy to treat Advanced Lung Cancer.

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.
A total of 40 patients may be enrolled over a period of 1-2 years.
Study Started
Aug 31
2016
Primary Completion
Mar 31
2018
Anticipated
Study Completion
Aug 31
2018
Anticipated
Last Update
Oct 07
2016
Estimate

Drug Chemotherapy

Cisplatin：60mg/m2，Gemcitabine：1g/ m2,Physiological saline 100ml:IV (in the vein) once a week with a total of six times.

Biological 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.

Precision cells combined with Chemotherapy treatment: Experimental

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 Active Comparator

Once a week with a total of six times before 60 days prior to the start of drawing blood.

Criteria 

Inclusion Criteria:

Age 18~65 years old, male or female;
Life expectancy≥6 months;
ECOG score: 0-3;
Advanced Malignancies (lung cancer) were diagnosed by pathological or clinical physicians;
Enough venous channel, no other contraindications to the separation and collection of white blood cells;
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；
Signed informed consent；
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:

Expected Overall survival < 6 months;
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.
Other serious diseases: nervous, mental disorders, immune regulatory diseases, metabolic diseases, infectious diseases, etc;
Other drugs, or other biological treatment,chemotherapy or radiotherapy are performed within a month.
Unable or unwilling to provide informed consent, or fail to comply with the test requirements.
No Results Posted