NCT03540199

Study of Activated Cytokine-induced Killer Armed With Bispecific Antibody for Advanced Kidney Cancer

Phase II Randomized Comparison Clinical Trial of Target Activated CIK for Advanced Kidney Cancer

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Fuda Cancer Hospital, Guangzhou · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a phase II Randomized comparison clinical trial of activated CIK armed with anti-CD3-MUC1 bispecific antibody for advanced kidney cancer. And the aim of this research is to study the clinical efficacy and safety of activated CIK armed with anti-CD3-MUC1 bispecific antibody for kidney cancer.

Detailed description

Primary kidney carcinoma is one of the most common malignancies in China,immunotherapy is considered to be one of the most promising means of human against cancer. This is a phase II clinical trial of single- center, The investigators plan to recruit for 90 patients with advanced kidney cancer,and all patients are divided into three groups.one group will receive cryotherapy, one group will receive conventional therapy，and the rest one will receive mixed liquor of activated CIK and anti-CD3-MUC1 bispecific antibody together with cryotherapy. The result of this study was statistic and analysed with the record of Response Evaluation Criteria In Solid Tumors(RECIST1.1) evaluation standard.

Conditions

• Advanced Kidney Cancer

Interventions

Type	Name	Description
BIOLOGICAL	Activated CIK and CD3-MUC1 Bispecific Antibody in Treating Kidney Cancer	CIK cells was activated by PD-1 inhibitor and bispecific antibody of anti-CD3/MUC1
PROCEDURE	cryotherapy	the maximum tumor length≥2 cm，cool down the lesion,result in degeneration, necrosis or loss of the lesion.

Timeline

• Start date: 2018-04-10
• Primary completion: 2020-05-20
• Completion: 2020-09-10
• First posted: 2018-05-30
• Last updated: 2020-10-19

Locations

1 site across 1 country: China