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

July 13, 2023 updated by: Xinxiang medical university

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Henan
      • Xinxiang, Henan, China, 453000
        • The First Affiliated Hospital of Xinxiang Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CCCR-NK92 cells immunotherapy
Preparation of CCCR-NK92 cells suspended in a saline and plasma solution.
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xinxiang medical university

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 29, 2018

Primary Completion (Actual)

November 30, 2020

Study Completion (Actual)

December 31, 2020

Study Registration Dates

First Submitted

July 11, 2018

First Submitted That Met QC Criteria

August 30, 2018

First Posted (Actual)

September 4, 2018

Study Record Updates

Last Update Posted (Actual)

July 14, 2023

Last Update Submitted That Met QC Criteria

July 13, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CNK-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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