Clinical Efficacy and Safety of Dendritic Cytotoxic Lymphocyte(DC-CTL) Cell Infusion in NSCLC Patients

NSCLC Clinical Trial

Official title:

Randomized, Controlled Study of the Safety and Efficacy of DC-CTL Immune Cell for Non-Small Cell Lung Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02766348
• Other study ID #: HYK-DC-CTL-NSCLC
• Status: Not yet recruiting
• Phase: Phase 2
• First received: May 5, 2016
• Last updated: May 6, 2016
• Start date: May 2016
• Est. completion date: December 2018

Study information

• Verified date: May 2016
• Source: Shenzhen Hornetcorn Bio-technology Company, LTD
• Contact: Zi L Zhang, researcher
• Phone: 18107168013
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Patients in group A will receive DC-CTL treatment and chemotherapy. Patients in group B will receive only chemotherapy.

Description:

60 patients with stage III-IV NSCLC will be randomly divided into group A (receive DC-CTL treatment with chemotherapy) or group B (Just receive chemotherapy), and the randomize ratio will be 1:1, patients in group A will receive 3 cycles of DC-CTL treatment (every 1 months) and 4 cycles of chemotherapy (every 2 weeks). Patients in group B will receive only 4 cycles chemotherapy(every 2 weeks).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• The patient who have signed the informed consent;

• Histologically confirmed with NSCLC at stage III-IV

• Expected survival time is more than 2 month;

• Eastern Cooperative Oncology Group(ECOG) performance status was 0-2

Exclusion Criteria:

• Hemoglobin <8.0 g/dL, White blood cell <3 x 10^9/L; Platelet count <75 x 10^9/L; alanine aminotransferase(ALT), aspartate aminotransferase(AST), blood urea nitrogen(BUN) and Creatinine(CR) more than normal limits on 3.0 times;

• Known or suspected allergy to the investigational agent or any agent given in association with this trial;

• Pregnant or lactating patients;

• Known history of Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV) or TreponemaPallidun (TP) infection;

• Patients who are suffering from serious autoimmune disease;

• Patients who had used long time or are using immunosuppressant;

• Patients who had active infection;

• Patients who are suffering from serious organ dysfunction;

• Patients who are suffering from other cancer;

• Other situations that the researchers considered unsuitable for this study.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• NSCLC

Intervention

Drug:
• gemcitabine
gemcitabine 1000mg/m2 IV on day 1 an day 8, repeat every 3 weeks

Biological:
• DC-CTL
8×10^9 DC-CTL cells for each infusion, IV(In the vein) for 3 cycles, each cycle received four infusions on day 14,16,30 and 32

Drug:
• cisplatinum
cisplatin 25mg/m2 IV on day 1,2 and 3, repeat every 3 weeks.

Locations

Country	Name	City	State
China	Jingzhou Central hospital Immunotherapy center	Jingzhou	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Shenzhen Hornetcorn Bio-technology Company, LTD

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progress-free survival		3 years	No
Secondary	Overall survival		3 years	No