Back to resultsCCCR-NK92 Cells Immunotherapy for Non-small Cell Lung Carcinoma
Primary Purpose
Non-small Cell Lung Cancer
Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
CCCR-NK92 cells
Sponsored by
About this trial
This is an interventional treatment trial for Non-small Cell Lung Cancer
Eligibility Criteria
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.
Sites / Locations
- The first Affiliated Hospital of Xinxiang Medical University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CCCR-NK92 cells immunotherapy
Arm Description
Preparation of CCCR-NK92 cells suspended in a saline and plasma solution.
Outcomes
Primary Outcome Measures
Number of participants with adverse events evaluated with CTCAE,version 4.0
Safety evaluation
Objective Response Rate
Non-small cell lung carcinoma to CCCR-NK92 cell infusions
Secondary Outcome Measures
Disease Control Rate
Progression-free Survival
Overall Survival
Full Information
NCT ID
NCT03656705
First Posted
July 11, 2018
Last Updated
July 13, 2023
Sponsor
Xinxiang medical university
1. Study Identification
Unique Protocol Identification Number
NCT03656705
Brief Title
CCCR-NK92 Cells Immunotherapy for Non-small Cell Lung Carcinoma
Official Title
Clinical Investigation of Chimeric Costimulatory Converting Receptor(CCCR)-Modified NK92 Cells in Previously Treated Advanced Non-small Cell Lung Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
September 29, 2018 (Actual)
Primary Completion Date
November 30, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xinxiang medical university
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CCCR-NK92 cells immunotherapy
Arm Type
Experimental
Arm Description
Preparation of CCCR-NK92 cells suspended in a saline and plasma solution.
Intervention Type
Biological
Intervention Name(s)
CCCR-NK92 cells
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of participants with adverse events evaluated with CTCAE,version 4.0
Description
Safety evaluation
Time Frame
3 months
Title
Objective Response Rate
Description
Non-small cell lung carcinoma to CCCR-NK92 cell infusions
Time Frame
up to one year
Secondary Outcome Measure Information:
Title
Disease Control Rate
Time Frame
up to one year
Title
Progression-free Survival
Time Frame
up to one year
Title
Overall Survival
Time Frame
up to one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
The first Affiliated Hospital of Xinxiang Medical University
City
Xinxiang
State/Province
Henan
ZIP/Postal Code
453000
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
CCCR-NK92 Cells Immunotherapy for Non-small Cell Lung Carcinoma
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