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Study Evaluating the Efficacy and Safety With CAR-T for Liver Cancer (EECLC)

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: NCT02729493
Recruitment Status : Unknown
Verified March 2017 by Sinobioway Cell Therapy Co., Ltd..
Recruitment status was:  Recruiting
First Posted : April 6, 2016
Last Update Posted : March 15, 2017
Sponsor:
Information provided by (Responsible Party):
Sinobioway Cell Therapy Co., Ltd.

Study Description
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Brief Summary:
This single-arm,multicenter Phase 2 trial will treat the patients who have relapsed or refractory liver cancer with an infusion of the patient's own T cells that have been genetically modified to express a chimeric antigen receptor(CAR)that will bind to tumour cells that express the EPCAM protein on the cell surface.The study will determine if these modified T cells help the body's immune system eliminate tumour cells.The trial will also study the safety of treatment with CAR-T,how long CAR-T cells stay in the patient's body and the impact of this treatment on survival.

Condition or disease Intervention/treatment Phase
Liver Neoplasms Biological: EPCAM-targeted CAR-T cells Not Applicable

Detailed Description:
This is a single-arm,multicenter Phase 2 study to evaluate the efficacy and safety of the CAR-T for Liver Cancer.The study will be conducted using a phaseⅠ /Ⅱ disign.The study will have the following sequential phases:Part A(screening leukapheresis,cell product preparation,and cytoreductive chemotherapy) and Part B(treatment and follow-up).The follow-up period for each paticipant is approximately 35 months after the final CAR-T infusion.The total duration of the study is expected to be approximately 3 years.A total of 25 patients may be enrolled over a period of 3 years.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Single Arm,Two Phase,Multicenter Trial to Evaluating the Efficacy and Safety of the CAR-T for Liver Cancer
Actual Study Start Date : November 14, 2015
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: Single-arm
Name:The Chimeric Antigen Receptor T Cell Immunotherapy (CAR-T) Dosage form：injection Dosage:100ml/time Frequency:0 days,the first day,the second day,28days,29days Duration:total five times
 Biological: EPCAM-targeted CAR-T cells
This study have only one arm that is CAR-T experimental arm. Firstly all participators will be attended the screening, who passed the screening for the treatment of CAR-T cells, the CAR-EPCAM-modified T cells can recognize and kill tumor cells in the body，follow-up 35 months.


Outcome Measures
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Primary Outcome Measures :
  1. Disease control rates [ Time Frame: CAR - T back to lose 0 days to 180 days ]
    Tumor complete remission number + partial response number + number of stable disease /Total number of cases being treated


Eligibility Criteria
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Information from the National Library of Medicine

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

Inclusion Criteria:

  1. According to UICC or liver cancer diagnosis and treatment guideline of diagnosis for hepatocellular carcinoma in patients with, the traditional treatment of invalid, advanced liver cancer, or postoperative relapse or refractory patients with hepatocellular carcinoma, and through flow cytometry or immune tissues (cell) chemistry, confirmation of tumor cells positive expression of relevant molecular targets;
  2. Age <=75 years old, both male and female;
  3. Is expected to survive more than 3 months;
  4. Physical condition is good: 0-2 score ECOG score;
  5. The lymphocyte count must > =0.4*10^9/L at the time of collection of peripheral blood;
  6. Vital organs (heart, kidney) function is normal, there is no major wound healing. No serious virus, bacterial infection;
  7. Non pregnancy and lactation;
  8. History of severe allergic reactions without biological products;
  9. Voluntary participation, good compliance,the subjects can cooperate with the experimental observation, and signed a written Informed Consent Form;
  10. At least one measurable lesion.

Exclusion Criteria:

  1. Pregnant or lactating women;
  2. Organ failure, such as heart: Class III and IV; liver: to Chlid grading of liver function grade C; kidney: kidney failure and uremia stage; lung: symptoms of severe respiratory failure; brain: disorder of consciousness;
  3. Patients with significant graft versus host disease (GVHD) after organ transplant history or allogeneic hematopoietic stem cell transplantation;
  4. Long term use of immunosuppressive drugs or people with severe autoimmune diseases;
  5. Any other chronic disease patients who have been treated with immune agents or hormone therapy;
  6. A serious infectious disease with severe, uncontrollable, wound healing
  7. Allergy to the interleukin and interferon cytokine;
  8. Coagulation abnormalities and severe thrombosis;
  9. Patients who have participated in other clinical trials or other clinical trials in the past 30 days
  10. The Investigator believe the patients should not participate in this experiment.
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): NCT02729493


Contacts
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Contact: Xianping Cheng, PI 13805512522 chengxianping@sina.com
Contact: mo chen, Investigator 13605511023 chemo@sohu.com

Locations
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China, Anhui
Anhui No.2 Province People's Hospital Recruiting
Hefei, Anhui, China, 230000
Sponsors and Collaborators
Sinobioway Cell Therapy Co., Ltd.
Investigators
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Principal Investigator: Xianping Cheng, PI associate chief physician
More Information
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Responsible Party: Sinobioway Cell Therapy Co., Ltd.
ClinicalTrials.gov Identifier: NCT02729493    
Other Study ID Numbers: ACCO-2015-06-03
First Posted: April 6, 2016    Key Record Dates
Last Update Posted: March 15, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plans to share data.
Keywords provided by Sinobioway Cell Therapy Co., Ltd.:
Liver Cancer CAR-T
Additional relevant MeSH terms:
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Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Neoplasms
Digestive System Diseases
Liver Diseases