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

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03656705
Enrollment
2
Registered
2018-09-04
Start date
2018-09-29
Completion date
2020-12-31
Last updated
2023-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-small Cell Lung Cancer

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).

Interventions

BIOLOGICALCCCR-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.

Sponsors

Xinxiang medical university
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Number of participants with adverse events evaluated with CTCAE,version 4.03 monthsSafety evaluation
Objective Response Rateup to one yearNon-small cell lung carcinoma to CCCR-NK92 cell infusions

Secondary

MeasureTime frame
Progression-free Survivalup to one year
Overall Survivalup to one year
Disease Control Rateup to one year

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026