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

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)