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

NCT01914263 | Unknown Phase 1 DMC

• 1 other identifier: AlliancellsPuRui-01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Hepatocellular Carcinoma; Renal Cell Carcinoma; Lung Cancer

Keywords

Cord blood-Derived cytokine induced killer cells,; Radical resection

Outcome Measures

Primary Outcomes (1)

• The incidence of adverse events following infusion of cord blood-derived cytokine-induced killer cells.

  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 Outcomes (2)

• Haematology

  Baseline, 1 day, 3 days 10 days and 30 days after cell infusion

• Serological analysis

  Baseline, 1day, 3 days 10 days and 30 days after cell infusion

Study Arms (2)

cytokine induced killer cell

EXPERIMENTAL

The eligible patients are infused a single dose of 8x10\^9 CIK cells.

Biological: cytokine induced killer cell

Control

NO INTERVENTION

The eligible patients are followed up for 30 days without any treatment.

Interventions

cytokine induced killer cell BIOLOGICAL

The eligible patients are infused with a single dose of 8x10\^9 cord blood-derived cytokine indued killer cells.

cytokine induced killer cell

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alliancells-PuRui Biocience Co., Ltd.: lead
• Zhongyuan Union Stem Cell Bio-engineering Corporation: collaborator

Study Sites (3)

Hannan BOAO Life infinity international anti-aging medical center

Qionghai, Hainan, 571434, China

RECRUITING

The 210 Hospital of Chinese People's Liberation Army

Dalian, Liaoning, 116021, China

RECRUITING

The 323 Hospital of Chinese People's Liberation Army

Xi'an, Shaanxi, 710054, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Carcinoma, Renal Cell; Lung Neoplasms

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• mingyuan wu, MD

  STUDY CHAIR

Central Study Contacts

liming wang, MD

CONTACT

86-29-84756502; wanglm@fmmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2013
• First Posted: August 2, 2013
• Study Start: March 1, 2014
• Primary Completion: April 1, 2016
• Study Completion: June 1, 2016
• Last Updated: April 16, 2015

Record last verified: 2014-07

Locations

CN (3)