Non-small Cell Lung Cancer
Conditions
Brief summary
The purpose of this clinical investigation is to evaluate the safety and effects of CCCR-modified NK92(CCCR-NK92)infusions in previously treated advanced non-small cell lung carcinoma(NSCLC).
Interventions
CCCR-NK92 cells will be administered intravenously over 1h. The starting dose of CCCR-NK92 cells will be 1×10e7-1×10e8,twice a week. The first evaluation of the efficacy after 3 weeks of treatment.
Sponsors
Study design
Eligibility
Inclusion criteria
* 1.Male and female subjects with non-small cell lung carcinoma in patients with no available curative treatment options who have limited prognosis(≧3 months)with currently available therapies will be enrolled. * 2.The last cytotoxic drug, radiotherapy or surgery≧4 weeks. * 3.HB≧90g/L, ANC≧1.5×10e9/L, PLT≧80×10e9/L, TBIL≦1.5×upper limit of nomal, ALT/AST≦2.5×upper limit of nomal, ALT/AST≦5×upper limit of nomal if have liver metastasis, Cr≦1.5×upper limit of nomal or CCr≧60ml/min.
Exclusion criteria
* 1.Pregnancy or breastfeeding. * 2.Known HIV, HBV or HCV infection. * 3.Active antoimmune disease. * 4.History of severe immediate hypersensitivity to any of the biological products including penicillin. * 5.Severe psychiatric disorder which might interfere with the study treatment or examination. * 6.Chronic heart failure NYHA≧III. * 7.Simultaneous participation in another clinical trial within 4 weeks.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with adverse events evaluated with CTCAE,version 4.0 | 3 months | Safety evaluation |
| Objective Response Rate | up to one year | Non-small cell lung carcinoma to CCCR-NK92 cell infusions |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free Survival | up to one year |
| Overall Survival | up to one year |
| Disease Control Rate | up to one year |
Countries
China