A Clinical Research of CAR T Cells Targeting EpCAM Positive Cancer
CARTEPC
1 other identifier
interventional
60
1 country
1
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of EpCAM-specific CAR T Cells infusion for EpCAM positive Cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jan 2017
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2017
CompletedFirst Submitted
Initial submission to the registry
January 3, 2017
CompletedFirst Posted
Study publicly available on registry
January 6, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedJanuary 6, 2017
January 1, 2017
1.9 years
January 3, 2017
January 4, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Toxicity profile of the EpCAM targeted CAR T cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0
Observe and handle the toxicity profile of the EpCAM targeted CAR T cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0
up to 24 months
Secondary Outcomes (2)
Survival time of anti-EpCAM CAR T cells in vivo
up to 24 months
Anti-tumor efficacy of CAR-T therapy by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1
up to 24 months
Study Arms (1)
CAR-T cell immunotherapy
EXPERIMENTALEnrolled patients will receive CAR-T cell immunotherapy with a novel specific Chimeric antigen receptor aiming at EpCAM antigen by infusion.
Interventions
This CAR-T cell immunotherapy with a novel specific Chimeric antigen receptor aiming at EpCAM antigen.
Eligibility Criteria
You may qualify if:
- Relapsed or refractory EpCAM positive cancer.
- KPS \> 60.
- Life expectancy\>3 months.
- Gender unlimited, age from 18 years to 80 years.
- Assessable lesions with a minimum size of 10mm by CT scan or MRI.
- Acceptable organ function Hematology:
- Absolute neutrophil count greater than 800/mm\^3 without the support of filgrastim.
- White blood cell (WBC) (\> 2000/mm\^3).
- Platelet count greater than 50,000/mm\^3.
- Hemoglobin greater than 9.0 g/dl.
- No other serious diseases(autoimmune disease, immunodeficiency etc.).
- Adequate cardiac function (LVEF ≥ 40%).
- No other tumors.
- Patients volunteer to participate in the research.
You may not qualify if:
- Allergic to cytokines.
- Uncontrolled active infection.
- Acute or chronic GVHD.
- MODS.
- Treated with T cell inhibitor.
- HIV affected.
- Pregnancy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
IEC of Chengdu Medical College
Chendu, 610500, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Xiao-an Li, PhD
First Affiliated Hospital of Chengdu Medical College
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 3, 2017
First Posted
January 6, 2017
Study Start
January 1, 2017
Primary Completion
December 1, 2018
Study Completion
December 1, 2020
Last Updated
January 6, 2017
Record last verified: 2017-01
Data Sharing
- IPD Sharing
- Will not share