CCCR-NK92 Cells Immunotherapy for Non-small Cell Lung Carcinoma

Non-small Cell Lung Cancer Clinical Trial

Official title:

Clinical Investigation of Chimeric Costimulatory Converting Receptor(CCCR)-Modified NK92 Cells in Previously Treated Advanced Non-small Cell Lung Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03656705
• Other study ID #: CNK-101
• Status: Completed
• Phase: Phase 1
• 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
• 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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

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