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

Phase 1

Completed

• Conditions: Non-small Cell Lung Cancer
• Interventions: Biological: CCCR-NK92 cells

• Registration Number: NCT03656705
• Lead Sponsor: Xinxiang medical university

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-07-11
• Study First Submitted QC: 2018-08-30
• Study First Posted: 2018-09-04
• Study Start: 2018-09-29
• Primary Completion: 2020-11-30
• Study Completion: 2020-12-31
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-13
• Last Update Posted: 2023-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CCCR-NK92 cells immunotherapy	CCCR-NK92 cells	Preparation of CCCR-NK92 cells suspended in a saline and plasma solution.

Primary Outcome Measures

Name	Time	Method
Objective Response Rate	up to one year	Non-small cell lung carcinoma to CCCR-NK92 cell infusions
Number of participants with adverse events evaluated with CTCAE,version 4.0	3 months	Safety evaluation

Secondary Outcome Measures

Name	Time	Method
Disease Control Rate	up to one year
Progression-free Survival	up to one year
Overall Survival	up to one year

Trial Locations

Locations (1)

The first Affiliated Hospital of Xinxiang Medical University; 🇨🇳 Xinxiang, Henan, China