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

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ClinicalTrials.gov Identifier: NCT02725125
Recruitment Status : Unknown
Verified March 2017 by Sinobioway Cell Therapy Co., Ltd..
Recruitment status was:  Recruiting
First Posted : March 31, 2016
Last Update Posted : March 23, 2017
Sponsor:
Information provided by (Responsible Party):
Sinobioway Cell Therapy Co., Ltd.

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.

Condition or disease Intervention/treatment Phase
Stomach 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 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 19 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 Stomach Cancer
Study Start Date : November 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: Stomach Cancer

Arm Intervention/treatment
Experimental: Single-arm
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
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.




Primary Outcome Measures :
  1. Disease control rates [ Time Frame: 0 to 180 days ]

Secondary Outcome Measures :
  1. Duration of remission [ Time Frame: 0 to 180 days ]


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 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.

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): NCT02725125


Contacts
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Contact: Yifu He, PI 18963789042 834638033@qq.com
Contact: Jian Chen, Investigator 15395000136 42002390@qq.com

Locations
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China, Anhui
Anhui Provincial Cancer Hospital Recruiting
Hefei, Anhui, China, 230071
Sponsors and Collaborators
Sinobioway Cell Therapy Co., Ltd.
Investigators
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Principal Investigator: Yifu He, PI Associate chief physician
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Responsible Party: Sinobioway Cell Therapy Co., Ltd.
ClinicalTrials.gov Identifier: NCT02725125    
Other Study ID Numbers: ACCO-2015-06-04
First Posted: March 31, 2016    Key Record Dates
Last Update Posted: March 23, 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.:
Stomach Cancer CAR-T
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases