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Completed

NCT Number: NCT03656705

CCCR-NK92 Cells Immunotherapy for 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).

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Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The first Affiliated Hospital of Xinxiang Medical University

Xinxiang, Henan, 453000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Number of participants with adverse events evaluated with CTCAE,version 4.0

    Time frame: 3 months

    Safety evaluation

  2. Objective Response Rate

    Time frame: up to one year

    Non-small cell lung carcinoma to CCCR-NK92 cell infusions

Secondary outcomes

  1. Disease Control Rate

    Time frame: up to one year

  2. Progression-free Survival

    Time frame: up to one year

  3. Overall Survival

    Time frame: up to one year

Sponsors and collaborators

Lead sponsor

Henan Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Sep 4, 2018
Registry last updated
Jul 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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