NCT02766348

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

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Shenzhen Hornetcorn Bio-technology Company, LTD · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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).

Conditions

• NSCLC

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2016-05-01
• Primary completion: 2017-12-01
• Completion: 2018-12-01
• First posted: 2016-05-09
• Last updated: 2016-05-09

Locations

1 site across 1 country: China