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

NCT03656705 | Completed Phase 1

• 1 other identifier: CNK-101
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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 (3)

• Disease Control Rate

  up to one year

• Progression-free Survival

  up to one year

• Overall Survival

  up to one year

Study Arms (1)

CCCR-NK92 cells immunotherapy

EXPERIMENTAL

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

Biological: CCCR-NK92 cells

Interventions

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.

CCCR-NK92 cells immunotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• The last cytotoxic drug, radiotherapy or surgery≧4 weeks.
• 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.

You may not qualify if:

• Pregnancy or breastfeeding.
• Known HIV, HBV or HCV infection.
• Active antoimmune disease.
• History of severe immediate hypersensitivity to any of the biological products including penicillin.
• Severe psychiatric disorder which might interfere with the study treatment or examination.
• Chronic heart failure NYHA≧III.
• Simultaneous participation in another clinical trial within 4 weeks.

Sponsors & Collaborators

• Xinxiang medical university: lead

Study Sites (1)

The first Affiliated Hospital of Xinxiang Medical University

Xinxiang, Henan, 453000, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2018
• First Posted: September 4, 2018
• Study Start: September 29, 2018
• Primary Completion: November 30, 2020
• Study Completion: December 31, 2020
• Last Updated: July 14, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)