Safety and Efficacy of DC-CIK in Patients With Advanced Non-Small-Cell Lung Cancer With Bone Metastases

A

Affiliated Hospital to Academy of Military Medical Sciences

Status and phase

Unknown
Phase 2
Phase 1

Conditions

Non-Small-Cell Lung Cancer With Bone Metastases

Treatments

Biological: genetically modified dendritic cells + cytokine-induced killer

Study type

Interventional

Funder types

Other

Identifiers

NCT02688686
307-CTC-DC/CIK-NSCLC-001

Details and patient eligibility

About

The purpose of this Phase I/II study is to evaluate the safety and efficacy of dendritic cells(DC) vaccine combined with cytokine-induced killer (CIK) cells in patients with Advanced Non-Small-Cell Lung Cancer with bone metastases. Experimental DC was transfected Ad5 vector coding mRNAs including suppressor of cytokine signaling (SOCS) 1, MUC1 and Survivin,are used for DC-based immunotherapy. Based on the results of our previously preclinical study with DC vaccine combined with CIK cells, the investigators plan to perform the clinical trial.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Histopathologically confirmed diagnosis of non-small cell lung cancer
  • Age >18 years at time of consent
  • Received standardized treatment of Non-Small-Cell Lung Cancer with bone metastases
  • KPS (Karnofsky performance scale) >60
  • Patient's written informed consent
  • No severe viral or bacterial infections
  • Predicted survival >3 months

Exclusion criteria

  • Clinically relevant diseases or infections (HBV, HCV, HIV)
  • Females who are pregnant or nursing
  • Immunosuppressant treatment
  • Currently participating in another clinical trial

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Central trial contact

Guo liang ding, master

Data sourced from clinicaltrials.gov

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