CCCR-NK92 Cells Immunotherapy for Non-small Cell Lung Car... | NCT03656705

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

NCT03656705

Sponsor

Henan Medical University

Status

Completed

Last Update Posted

Jul 14, 2023Actual

Enrollment

2Actual

Phase

Phase 1

Conditions

Non-small Cell Lung Cancer

Interventions

CCCR-NK92 cells

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 29, 2018Actual

Primary Completion Date

Nov 30, 2020Actual

Completion Date

Dec 31, 2020Actual

First Submitted Date

Jul 11, 2018

First Submission Date that Met QC Criteria

Aug 30, 2018

First Posted Date

Sep 4, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 13, 2023

Last Update Posted Date

Jul 14, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

2Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CCCR-NK92 cells immunotherapy	Experimental	Preparation of CCCR-NK92 cells suspended in a saline and plasma solution.	Biological: CCCR-NK92 cells

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CCCR-NK92 cells	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.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Disease Control Rate		up to one year
Progression-free Survival		up to one year
Overall Survival

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The first Affiliated Hospital of Xinxiang Medical University		Xinxiang	Henan	453000	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002289	Carcinoma, Non-Small-Cell Lung

Ancestor Terms

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms

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Browse Branches

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