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

Primary Purpose

Liver Neoplasms

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

EPCAM-targeted CAR-T cells

About this trial

This is an interventional treatment trial for Liver Neoplasms focused on measuring Liver Cancer CAR-T

Eligibility Criteria

undefined - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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;
Age <=75 years old, both male and female;
Is expected to survive more than 3 months;
Physical condition is good: 0-2 score ECOG score;
The lymphocyte count must > =0.4*10^9/L at the time of collection of peripheral blood;
Vital organs (heart, kidney) function is normal, there is no major wound healing. No serious virus, bacterial infection;
Non pregnancy and lactation;
History of severe allergic reactions without biological products;
Voluntary participation, good compliance,the subjects can cooperate with the experimental observation, and signed a written Informed Consent Form;
At least one measurable lesion.

Exclusion Criteria:

Pregnant or lactating women;
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;
Patients with significant graft versus host disease (GVHD) after organ transplant history or allogeneic hematopoietic stem cell transplantation;
Long term use of immunosuppressive drugs or people with severe autoimmune diseases;
Any other chronic disease patients who have been treated with immune agents or hormone therapy;
A serious infectious disease with severe, uncontrollable, wound healing
Allergy to the interleukin and interferon cytokine;
Coagulation abnormalities and severe thrombosis;
Patients who have participated in other clinical trials or other clinical trials in the past 30 days
The Investigator believe the patients should not participate in this experiment.

Sites / Locations

Anhui No.2 Province People's HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single-arm

Arm Description

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

Outcomes

Primary Outcome Measures

Disease control rates

Tumor complete remission number + partial response number + number of stable disease /Total number of cases being treated

Secondary Outcome Measures

Full Information

NCT ID

NCT02729493

First Posted

March 23, 2016

Last Updated

March 13, 2017

Sponsor

Sinobioway Cell Therapy Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT02729493

Brief Title

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

Acronym

EECLC

Official Title

Single Arm,Two Phase,Multicenter Trial to Evaluating the Efficacy and Safety of the CAR-T for Liver Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

March 2017

Overall Recruitment Status

Unknown status

Study Start Date

November 14, 2015 (Actual)

Primary Completion Date

November 2019 (Anticipated)

Study Completion Date

November 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sinobioway Cell Therapy Co., Ltd.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Liver Neoplasms

Keywords

Liver Cancer CAR-T

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Single-arm

Arm Type

Experimental

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

EPCAM-targeted CAR-T cells

Intervention Description

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.

Primary Outcome Measure Information:

Title

Disease control rates

Description

Tumor complete remission number + partial response number + number of stable disease /Total number of cases being treated

Time Frame

CAR - T back to lose 0 days to 180 days

10. Eligibility

Sex

All

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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; Age <=75 years old, both male and female; Is expected to survive more than 3 months; Physical condition is good: 0-2 score ECOG score; The lymphocyte count must > =0.4*10^9/L at the time of collection of peripheral blood; Vital organs (heart, kidney) function is normal, there is no major wound healing. No serious virus, bacterial infection; Non pregnancy and lactation; History of severe allergic reactions without biological products; Voluntary participation, good compliance,the subjects can cooperate with the experimental observation, and signed a written Informed Consent Form; At least one measurable lesion. Exclusion Criteria: Pregnant or lactating women; 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; Patients with significant graft versus host disease (GVHD) after organ transplant history or allogeneic hematopoietic stem cell transplantation; Long term use of immunosuppressive drugs or people with severe autoimmune diseases; Any other chronic disease patients who have been treated with immune agents or hormone therapy; A serious infectious disease with severe, uncontrollable, wound healing Allergy to the interleukin and interferon cytokine; Coagulation abnormalities and severe thrombosis; Patients who have participated in other clinical trials or other clinical trials in the past 30 days The Investigator believe the patients should not participate in this experiment.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Xianping Cheng, PI

Phone

13805512522

chengxianping@sina.com

First Name & Middle Initial & Last Name or Official Title & Degree

mo chen, Investigator

Phone

13605511023

chemo@sohu.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Xianping Cheng, PI

Organizational Affiliation

associate chief physician

Official's Role

Principal Investigator

Facility Information:

Facility Name

Anhui No.2 Province People's Hospital

City

Hefei

State/Province

Anhui

ZIP/Postal Code

230000

Country

China

Individual Site Status

Recruiting

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

No plans to share data.

Learn more about this trial

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

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