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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03656705
Other study ID # CNK-101
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date September 29, 2018
Est. completion date December 31, 2020

Study information

Verified date July 2023
Source Xinxiang medical university
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Completed
Enrollment 2
Est. completion date December 31, 2020
Est. primary completion date November 30, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
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.

Study Design


Intervention

Biological:
CCCR-NK92 cells
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.

Locations

Country Name City State
China The first Affiliated Hospital of Xinxiang Medical University Xinxiang Henan

Sponsors (1)

Lead Sponsor Collaborator
Xinxiang medical university

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of participants with adverse events evaluated with CTCAE,version 4.0 Safety evaluation 3 months
Primary Objective Response Rate Non-small cell lung carcinoma to CCCR-NK92 cell infusions up to one year
Secondary Disease Control Rate up to one year
Secondary Progression-free Survival up to one year
Secondary Overall Survival up to one year
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