A Clinical Research of CAR T Cells Targeting EpCAM Positive Cancer (CARTEPC)
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ClinicalTrials.gov Identifier: NCT03013712 |
Recruitment Status : Unknown
Verified January 2017 by First Affiliated Hospital of Chengdu Medical College.
Recruitment status was: Recruiting
First Posted : January 6, 2017
Last Update Posted : January 6, 2017
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Condition or disease | Intervention/treatment | Phase |
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Colon Cancer Esophageal Carcinoma Pancreatic Cancer Prostate Cancer Gastric Cancer Hepatic Carcinoma | Biological: CAR-T cell immunotherapy | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 60 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Clinical Research of CAR T Cells Targeting EpCAM Positive Cancer |
Study Start Date : | January 2017 |
Estimated Primary Completion Date : | December 2018 |
Estimated Study Completion Date : | December 2020 |

Arm | Intervention/treatment |
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Experimental: CAR-T cell immunotherapy
Enrolled patients will receive CAR-T cell immunotherapy with a novel specific Chimeric antigen receptor aiming at EpCAM antigen by infusion.
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Biological: CAR-T cell immunotherapy
This CAR-T cell immunotherapy with a novel specific Chimeric antigen receptor aiming at EpCAM antigen. |
- Toxicity profile of the EpCAM targeted CAR T cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0 [ Time Frame: up to 24 months ]Observe and handle the toxicity profile of the EpCAM targeted CAR T cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0
- Survival time of anti-EpCAM CAR T cells in vivo [ Time Frame: up to 24 months ]Detect the existence of CAR-T cells in the blood of participants through flow cytometry
- Anti-tumor efficacy of CAR-T therapy by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 [ Time Frame: up to 24 months ]Anti-tumor efficacy of CAR-T therapy for patients with EpCAM positive cancers was assessed by RECIST v1.1

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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
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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.
Exclusion Criteria:
- Allergic to cytokines.
- Uncontrolled active infection.
- Acute or chronic GVHD.
- MODS.
- Treated with T cell inhibitor.
- HIV affected.
- Pregnancy.

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): NCT03013712
Contact: Yan Zhou, PhD | +86-18981941992 | zqlvzy319@163.com |
China | |
IEC of Chengdu Medical College | Recruiting |
Chendu, China, 610500 | |
Contact: Xiao-an Li, post doctor +8613680868858 435445611@qq.com |
Study Chair: | Xiao-an Li, PhD | First Affiliated Hospital of Chengdu Medical College |
Responsible Party: | First Affiliated Hospital of Chengdu Medical College |
ClinicalTrials.gov Identifier: | NCT03013712 |
Other Study ID Numbers: |
CARTEPC-001 |
First Posted: | January 6, 2017 Key Record Dates |
Last Update Posted: | January 6, 2017 |
Last Verified: | January 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Carcinoma Esophageal Neoplasms Carcinoma, Hepatocellular Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms by Site Digestive System Neoplasms |
Digestive System Diseases Gastrointestinal Neoplasms Gastrointestinal Diseases Head and Neck Neoplasms Esophageal Diseases Adenocarcinoma Liver Neoplasms Liver Diseases |