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Study of High Efficient Killing Cell Therapy for Advanced NSCLC

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ClinicalTrials.gov Identifier: NCT03193567
Recruitment Status : Recruiting
First Posted : June 21, 2017
Last Update Posted : March 28, 2019
Sponsor:
Collaborator:
Shanghai Houchao Biotechnology Co., Ltd
Information provided by (Responsible Party):
Hecheng Li M.D., Ph.D, Ruijin Hospital

Brief Summary:
The purpose of this study to preliminarily evaluate the safety and efficacy of High Efficient Killing Cell Therapy for refractory and advanced non-small cell lung cancer

Condition or disease Intervention/treatment Phase
Non Small Cell Lung Cancer Biological: HEKT cell Phase 1

Detailed Description:
Patients with pathological confirmed non-small cell lung cancer with no standard treatment are enrolled. The patients fails in previous at least 2 lines of chemotherapy and 1 line of targeted therapy where applicable. This is a prospective exploratory trial.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Study of High Efficient Killing Cell Therapy for Advanced Non Small Cell Lung Cancer
Actual Study Start Date : September 14, 2017
Estimated Primary Completion Date : May 1, 2022
Estimated Study Completion Date : May 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: HEKT cell
Enrolled patients will receive HEKT cell injection, 10-days interval, totally 3 times.
Biological: HEKT cell
3 cycles of HEKT cell treatment
Other Name: High Efficient Killing Cell Therapy




Primary Outcome Measures :
  1. safety:safety index of blood, heart, lung, kidney and brain function damaged mainly during the treatment [ Time Frame: 2 years ]
    Occurrence of study related adverse events as assessed by CTCAE v4.0


Secondary Outcome Measures :
  1. efficacy: complete response; partial response; stable disease; progression disease; progression free survival. [ Time Frame: 2 years ]
    The efficacy of the treatment is assessed according to (RECIST1.1)


Other Outcome Measures:
  1. Progression free survival [ Time Frame: 2 years ]
    Progression free survival is defined as the time from the day in which the patient is enrolled to the date on which tumor progresses or the date on which the patient dies for any cause.

  2. Overall survival [ Time Frame: 2 years ]
    Overall survival is defined as the time from the day in which the patient is enrolled to the date on which the patient dies for any cause.

  3. Imaging evaluation before and after treatment [ Time Frame: 0 day and 60 day ]
    the SUV index of PET-CT before cell injection and after the whole course of the treatment



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female patients' age from 18 years to 70 years.
  • Patients who have a life expectancy of at least 3 months.
  • pathologically confirmed non-small cell lung cancer.
  • failed in previous standard chemotherapy and targeted therapy.
  • Karnofsky performance status 0-1.
  • adequate organ functions.

Exclusion Criteria:

  • Pregnant and lactating women.
  • Patients with T cell lymphoma, syphilis, AIDS or combination
  • Patients with highly allergic or have a history of severe allergies
  • Patients with severe hepatic or renal dysfunction
  • Patients with severe autoimmune disease or who is being treated with immunosuppressive agents
  • Patients with severe infection not controlled or High fever
  • Patients with organ transplantation or waiting for organ transplantation.
  • Patients with brain metastasis
  • Patients with severe coagulopathy (e.g. hemophilia)
  • Patients without adequate ability to understand, sign informed consents and take part in the clinical research voluntarily.

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): NCT03193567


Contacts
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Contact: Lei H Du, M.S 13918570392 sealing821201@hotmail.com

Locations
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China
Ruijin Hospital Recruiting
Shanghai, China
Contact: Lei hai Du, Master         
Sponsors and Collaborators
Ruijin Hospital
Shanghai Houchao Biotechnology Co., Ltd

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Responsible Party: Hecheng Li M.D., Ph.D, Professor, Ruijin Hospital
ClinicalTrials.gov Identifier: NCT03193567     History of Changes
Other Study ID Numbers: HEKT-63
First Posted: June 21, 2017    Key Record Dates
Last Update Posted: March 28, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms