Safety Study of Cord Blood-derived Cytokine-induced Killer Cells in Patients With Solid Tumor After Radical Resection

Lung Cancer Clinical Trial

Official title: Phase 1 Study of Cord Blood-derived Cytokine-induced Killer Cells in Patients With Solid Tumor After Radical Resection

Status Recruiting

Clinical Trial Summary

Cytokine-induced killer (CIK) cells are a heterogeneous subset of ex-vivo expanded T lymphocytes which present a mixed T-NK phenotype and are endowed with a major histocompatibility complex-unrestricted antitumor activity. Radical surgery is a good therapy for patients with solid tumor.However, tumor relapse is still a risk for those patients. Our hypothsis is that cytokine induced killer cells maybe decrease the recurrence rate. The purpose of this study is to evaluate the safety and tolerability of cord blood-derived cytokine induced killer cells in patients with solid tumor following radical resection.

Clinical Trial Description

It was estimated that 2.6 million people suffer from cancer and 1.8 million die of cancer in China yearly according to the Annual Report of Cancer Registration in China 2012. So far, the main treatment modalities for tumors have been surgery, radiotherapy and chemotherapy. However, tumor relapse is still a risk for those patients underwent the conventional therapy. With the development of oncology and immunology in recent years, immunotherapy represents a novel path to obtain a durable and long-lasting response in cancer patients. Cytokine-induced killer (CIK) cells are a heterogeneous subset of ex-vivo expanded T lymphocytes which present a mixed T-NK phenotype and are endowed with a MHC-unrestricted antitumor activity. CIK cells are expanded conventionally from peripheral blood mononuclear cells by addition of a variety of cytokines in vitro culture.

Autologous CIK cells infusion therapy for patients with malignancies is reported world widely. However, there are several drawbacks for autologous CIK limiting its clinical application. For example, limited cell numbers, decreased cell activities, and unavailable in time etc. Cord blood, as a novel source of non-senescent lymphocytes for tumor immunotherapy, has been focused on recently. Accumulating preclinical studies have shown that cord blood-derived CIK cells are potent anti-tumor effectors using in adoptive cancer immunotherapy. However it is unclear whether administration of cord blood-derived CIK cells is safe in patients with malignancies. Our previous studies demonstrated that clinical scale expansion of CIK from cord blood is feasible. The cord blood-derived CIK cells exhibit antitumor effect in vitro and in vivo (tumor bearing nude mice) against a variety of tumor cells including ZR751, MCF7, HepG2, SMMC-7721, Hela, A375, DU145, H1299 and A549. Furthermore, intravenous infusion of a single dose of 3X10^8 cord blood-derived CIK cells in mice is safe.

The purpose of this study is to evaluate the safety and tolerability of cord blood-derived CIK cells in patients with solid tumor following radical resection. ;

Study Design

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Carcinoma, Renal Cell
• Hepatocellular Carcinoma
• Lung Cancer
• Renal Cell Carcinoma

• NCT number: NCT01914263
• Study type: Interventional
• Source: Alliancells-PuRui Biocience Co., Ltd.
• Contact: liming wang, MD
• Phone: 86-29-84756502
• Email: wanglm@fmmu.edu.cn
• Status: Recruiting
• Phase: Phase 1
• Start date: March 2014
• Completion date: June 2016