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

April 15, 2015 updated by: Alliancells-PuRui Biocience Co., Ltd.

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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 Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hainan
      • Qionghai, Hainan, China, 571434
        • Recruiting
        • Hannan BOAO Life infinity international anti-aging medical center
    • Liaoning
      • Dalian, Liaoning, China, 116021
        • Recruiting
        • The 210 Hospital of Chinese People's Liberation Army
        • Contact:
        • Principal Investigator:
          • Dayue Han, MD
    • Shaanxi
      • Xi'an, Shaanxi, China, 710054
        • Recruiting
        • The 323 Hospital of Chinese People's Liberation Army
        • Contact:
        • Principal Investigator:
          • Liming Wang, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female patients over 18 years of age.
  • Patients who give written informed consent.
  • Patients with solid tumor already had radical resection
  • Definition of radical resection in this study:
  • All tumors were moved out, with a clean resection margin.
  • No distance metastasis.
  • No major post-operative complication.
  • Without any anti-cancer medication within the past 15 days.
  • The following laboratory parameters: Platelet count >= 70 x 109/L; Hemoglobin >= 8.5 g/dL; Albumin >= 3.5 g/dL; Total bilirubin <= 25umol/L; Alanine transaminase (ALT) and AST <= 2.5 x upper limit of normal; Serum creatinine <= 1.5 x the upper limit of normal; Prothrombin time (PT) <= 3 seconds above control.

Exclusion Criteria:

  • History of cardiac disease.
  • Active clinically serious infections
  • Known history of human immunodeficiency virus (HIV) infection
  • Known Central Nervous System tumors including metastatic brain disease.
  • Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
  • History of organ allograft.
  • Known or suspected allergy to the investigational agent or any agent given in association with this trial.
  • Pregnant or breast-feeding patients.
  • Any condition that is unstable or which could jeopardize the safety of the patient and his/her compliance in the study.
  • Any condition that is unstable or which could jeopardize the safety of the patient and his/her compliance in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: cytokine induced killer cell
The eligible patients are infused a single dose of 8x10^9 CIK cells.
Biological: cytokine induced killer cell
The eligible patients are infused with a single dose of 8x10^9 cord blood-derived cytokine indued killer cells.
No Intervention: Control
The eligible patients are followed up for 30 days without any treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence of adverse events following infusion of cord blood-derived cytokine-induced killer cells.
Time Frame: 30 days post-infusion
The primary outcome measures for safety will include the incidence of fever,chill,rash and Graft-versus-Host Disease (GVHD).
30 days post-infusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Haematology
Time Frame: Baseline, 1 day, 3 days 10 days and 30 days after cell infusion
These parameters include erythrocytes, leukocytes, platelets, T cell, B cell, Natural killer cell, CD4/CD8, Th1/Th2, Th17 cell and Treg cell.
Baseline, 1 day, 3 days 10 days and 30 days after cell infusion
Serological analysis
Time Frame: Baseline, 1day, 3 days 10 days and 30 days after cell infusion
immunoglobulin G, immunoglobulin A, immunoglobulin D, immunoglobulin E and immunoglobulin M. Albumin (ALB), Alanine aminotransferase (ALT), Aspartate Aminotransferase (AST), Prealbumin(PA), total bilirubin (TB), and direct bilirubin (DB); Blood urea nitrogen(BUN), Urea (UA), and Crea (Cr); Total cholesterol (TC), high density lipoprotein cholesterol (HDL-C), low density lipoprotein cholesterol (LDL-C), triglycerides (TG), very low density lipoprotein cholesterol (VLDL-C), and Non-HDL-C; blood sugar;
Baseline, 1day, 3 days 10 days and 30 days after cell infusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alliancells-PuRui Biocience Co., Ltd.

Collaborators

Zhongyuan Union Stem Cell Bio-engineering Corporation

Investigators

  • Study Chair: mingyuan wu, MD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Anticipated)

April 1, 2016

Study Completion (Anticipated)

June 1, 2016

Study Registration Dates

First Submitted

July 29, 2013

First Submitted That Met QC Criteria

July 30, 2013

First Posted (Estimate)

August 2, 2013

Study Record Updates

Last Update Posted (Estimate)

April 16, 2015

Last Update Submitted That Met QC Criteria

April 15, 2015

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AlliancellsPuRui-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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