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

NCT ID: NCT03656705

Last Updated: 2023-07-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-29
• Study Completion Date: 2020-12-31

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).

Conditions

Non-small Cell Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CCCR-NK92 cells immunotherapy

Preparation of CCCR-NK92 cells suspended in a saline and plasma solution.

Group Type: EXPERIMENTAL

CCCR-NK92 cells

Intervention Type: BIOLOGICAL

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.

Interventions

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.

Intervention Type: BIOLOGICAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xinxiang medical university

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The first Affiliated Hospital of Xinxiang Medical University

Xinxiang, Henan, China

Countries

China

Other Identifiers

CNK-101

Identifier Type: -

Identifier Source: org_study_id