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Study Evaluating the Efficacy and Safety With CAR-T for Stomach Cancer (EECSC)

Primary Purpose

Stomach Neoplasms

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
EPCAM-targeted CAR-T cells
Sponsored by
Sinobioway Cell Therapy Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

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

Eligibility Criteria

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

Inclusion Criteria:

  1. According to UICC or gastric cancer diagnosis and treatment guideline of diagnosis for patients with gastric cancer, first-line and second-line chemotherapy of advanced gastric cancer, and through flow cytometry or immune tissues (cell) chemistry, confirm the 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.

Sites / Locations

  • Anhui Provincial Cancer 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:0days,the first day,the second day,28 days,29 days Duration:total five times

Outcomes

Primary Outcome Measures

Disease control rates

Secondary Outcome Measures

Duration of remission

Full Information

First Posted
March 25, 2016
Last Updated
March 21, 2017
Sponsor
Sinobioway Cell Therapy Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02725125
Brief Title
Study Evaluating the Efficacy and Safety With CAR-T for Stomach Cancer
Acronym
EECSC
Official Title
Single-arm,Two Phase,Multicenter Trial to Evaluating the Efficacy and Safety of the CAR-T for Stomach Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Unknown status
Study Start Date
November 2015 (undefined)
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 stomach 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 tumor 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 tumor 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 Stomach Cancer. The study will be conducted using a phaseⅠ /Ⅱ design.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 participant 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 19 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
Stomach Neoplasms
Keywords
Stomach 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
19 (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:0days,the first day,the second day,28 days,29 days 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
Time Frame
0 to 180 days
Secondary Outcome Measure Information:
Title
Duration of remission
Time Frame
0 to 180 days

10. Eligibility

Sex
All
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: According to UICC or gastric cancer diagnosis and treatment guideline of diagnosis for patients with gastric cancer, first-line and second-line chemotherapy of advanced gastric cancer, and through flow cytometry or immune tissues (cell) chemistry, confirm the 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
Yifu He, PI
Phone
18963789042
Email
834638033@qq.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jian Chen, Investigator
Phone
15395000136
Email
42002390@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yifu He, PI
Organizational Affiliation
Associate chief physician
Official's Role
Principal Investigator
Facility Information:
Facility Name
Anhui Provincial Cancer Hospital
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230071
Country
China
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No plans to share data.

Learn more about this trial

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

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