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Safety and Efficiency of γδ T Cell Against Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03183232
Recruitment Status : Completed
First Posted : June 12, 2017
Last Update Posted : July 13, 2020
Sponsor:
Collaborator:
Jinan University Guangzhou
Information provided by (Responsible Party):
Fuda Cancer Hospital, Guangzhou

Study Description
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Brief Summary:
In this study, effects of γδT cells on human Lung Cancer in combination with tumor reducing surgery, for example, cryosurgery going to be investigated

Condition or disease Intervention/treatment Phase
Lung Cancer Procedure: Cryosurgery or IRE surgery Biological: γδ T cell Other: γδ T cells/ A Cryosurgery or IRE Phase 1 Phase 2

Detailed Description:

Lung tumor will be removed using tumor reducing surgery such as cryosurgery. PBMC of the patient will be separated from peripheral blood. After making them potential cancer killer γδ T Cell and DC-CIK, they will be infused to the patients as an immunotherapy treatment.

NOTE: Originally, our designed proposal was to use autologous PBMCs from cancer patients to ex vivo expand Vγ9Vδ2-T cells, and then perform adoptive transfer therapy. However, PBMCs of majority of cancer patients could not be effectively expanded, including cell number, cell purity and cell function could not meet the requirements of reinfusion. Meanwhile, those patients could not tolerate 100ml of blood drawing for culture every 2 ~ 3 weeks.

Therefore, we submitted new clinical study application to the ethical committee of the Fuda Hospital affiliated with Jinan University (Guangzhou, PR. China) by changing the autologous protocol with the allogeneic protocol. After the allogeneic protocol was approved, we adapted allogeneic cells instead of autologous in our subsequentially clinical study.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: γδ T Cell Immunotherapy for Treatment of Lung Cancer
Actual Study Start Date : June 15, 2017
Actual Primary Completion Date : June 15, 2018
Actual Study Completion Date : June 15, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: Group A
In this group, the patients will receive under CT Cryosurgery or IRE surgery to control the local tumor
 Procedure: Cryosurgery or IRE surgery
Cryosurgery or IRE surgery will be used in local tumor
Experimental: Group B
In this group, the patients will receive multiple high-activity γδ T cell immunotherapies. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell)
 Biological: γδ T cell
γδ T cells will be used against Lung Cancer
Experimental: Group C
In this group, the patients will receive multiple high-activity γδ T cell immunotherapies and Cryosurgery or IRE surgery
 Other: γδ T cells/ A Cryosurgery or IRE
Combination γδ T cell and Cryosurgery or IRE surgery will be used in Lung Cancer


Outcome Measures
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Primary Outcome Measures :
  1. Relief degree of tumors [ Time Frame: 3 months ]
    It will be evaluated by the Response Evaluation Criteria in Solid Tumors

  2. Progress free survival（PFS) [ Time Frame: 1 year ]
  3. Overall survival（OS） [ Time Frame: 3 years ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Age: 18-75 Karnofsky performance status >50 Diagnosis with Lung Cancer based on histology or the current accepted radiological measures Classification tumor,nodes,metastasis-classification(TNM) stage: Ⅱ,Ⅲ,Ⅳ Will receive cryosurgery, IRE, gd T cells Life expectancy: Greater than 3 months Ability to understand the study protocol and a willingness to sign a written informed consent document

Exclusion Criteria:

Patients with other kinds of cancer History of coagulation disorders or anemia Patients with heart disease

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03183232


Locations
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China, Guangdong
Biotherapy center in Fuda cancer hospital
Guangzhou, Guangdong, China, 510665
Sponsors and Collaborators
Fuda Cancer Hospital, Guangzhou
Jinan University Guangzhou
Investigators
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Principal Investigator: Jibing Chen, PhD Biological treatment center in Fuda cancer hospital Guangzhou, Guangdong, China, 510000
More Information
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Responsible Party: Fuda Cancer Hospital, Guangzhou
ClinicalTrials.gov Identifier: NCT03183232    
Other Study ID Numbers: Gd T cell and lung Ca
First Posted: June 12, 2017    Key Record Dates
Last Update Posted: July 13, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fuda Cancer Hospital, Guangzhou:
Immunotherapy, γδ T Cell, Lung Cancer
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases