NCT02725125

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 25, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 31, 2016

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2019

Completed
Last Updated

March 23, 2017

Status Verified

March 1, 2017

Enrollment Period

4 years

First QC Date

March 25, 2016

Last Update Submit

March 21, 2017

Conditions

Stomach Neoplasms

Keywords

Stomach Cancer CAR-T

Outcome Measures

Primary Outcomes (1)

  • Disease control rates

    0 to 180 days

Secondary Outcomes (1)

  • Duration of remission

    0 to 180 days

Study Arms (1)

Single-arm

EXPERIMENTAL

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

Interventions

EPCAM-targeted CAR-T cellsBIOLOGICAL

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.

Single-arm

Eligibility Criteria

AgeUp to 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Anhui Provincial Cancer Hospital

Hefei, Anhui, 230071, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • Yifu He, PI

    Associate chief physician

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yifu He, PI

CONTACT

18963789042834638033@qq.com

Jian Chen, Investigator

CONTACT

1539500013642002390@qq.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2016

First Posted

March 31, 2016

Study Start

November 1, 2015

Primary Completion

November 1, 2019

Study Completion

November 1, 2019

Last Updated

March 23, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

No plans to share data.

Locations

CN(1)