NCT03619954

NK Cells Infusion for Advanced Malignancies

A Clinical Research of Natural Killer (NK) Cells Infusion for the Treatment of Advanced Malignant Tumor

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Anhui Provincial Hospital · Other Government
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to explore the safety and efficacy of natural killer (NK) cell infusion as treatment for patients with advanced malignant tumors after multiline therapy, and to evaluate the pharmacokinetics of NK cells in patients

Conditions

• Immunotherapy

Interventions

Type	Name	Description
BIOLOGICAL	NK cells infusion	Pretreatment：patients enrolled in this study will receive 20 mg/kg of cyclophosphamide for solid tumor or 20-60 mg/kg of cyclophosphamide for hematological tumor once daily for 3 times. NK cells infusion is allowed within 2-14 days after treatment. NK cells infusion：30-60 minutes before infusion，ant-allergic agents are applied (promethazine 25mg,i.m. ; Cimetidine 0.4g i.v. ; diphenhydramine 50mg po.). NK cells are intravenously infused into patients with 15-30 minutes every other day for one to three times. The number of every infused NK cells is 1-3×10\^7/kg, counted as the number of CD56+ cells. Patients with severe pleural or ascites can also receive pleural or abdominal cavity perfusion simultaneously. The total number of infused NK cells is no more than 5×10\^9 cells. 4 hours after NK cells infusion，IL-2 is applied every other day for six times

Timeline

• Start date: 2018-07-01
• Primary completion: 2019-07-01
• Completion: 2020-07-01
• First posted: 2018-08-08
• Last updated: 2018-08-08

Locations

1 site across 1 country: China