A Clinical Research of CAR T Cells Targeting EpCAM Positive Cancer

Prostate Cancer Clinical Trial

— CARTEPC  

Official title:

A Clinical Research of CAR T Cells Targeting EpCAM Positive Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03013712
• Other study ID #: CARTEPC-001
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: January 3, 2017
• Last updated: January 4, 2017
• Start date: January 2017
• Est. completion date: December 2020

Study information

• Verified date: January 2017
• Source: First Affiliated Hospital of Chengdu Medical College
• Contact: Yan Zhou, PhD
• Phone: +86-18981941992
• Email: zqlvzy319[@]163.com
• Is FDA regulated: No
• Health authority: China: Health and Family Planning Commission of Sichuan Province
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety and efficacy of EpCAM-specific CAR T Cells infusion for EpCAM positive Cancer.

Description:

This study is being conducted to evaluate the safety and efficacy of Chimeric antigen receptor (CAR) T cells targeting EpCAM in treating patients with EpCAM positive cancer. In the research, the investigators design a novel CAR consists of a EpCAM targeting antibody scFv with two intracellular signaling domains derived from CD3 zeta and CD28. Autologous T cells will be gene-engineered with the CAR gene using a lentivirus vector. Prior to T cell infusion, the patients will be subjected to preconditioning treatment. The infusion dose is (1-10)×106 EpCAM-CAR positive T cells/kg, and the specific cells numbers depends on the situation of individual CAR-T cells preparation. The way of infusion is vascular interventional mediated or endoscopy, and the cells perfusion process would lasts 15min to 30min, and the specific time depends on patent's tumor-burdened state. After T cell infusion, the patients will be evaluated for 24 months for adverse reactions, persistence of CAR T cells and efficacy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2020
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Relapsed or refractory EpCAM positive cancer.

2. KPS > 60.

3. Life expectancy>3 months.

4. Gender unlimited, age from 18 years to 80 years.

5. Assessable lesions with a minimum size of 10mm by CT scan or MRI.

6. 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.

7. No other serious diseases(autoimmune disease, immunodeficiency etc.).

8. Adequate cardiac function (LVEF = 40%).

9. No other tumors.

10. Patients volunteer to participate in the research.

Exclusion Criteria:

1. Allergic to cytokines.

2. Uncontrolled active infection.

3. Acute or chronic GVHD.

4. MODS.

5. Treated with T cell inhibitor.

6. HIV affected.

7. Pregnancy.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Colon Cancer
• Esophageal Carcinoma
• Esophageal Neoplasms
• Gastric Cancer
• Hepatic Carcinoma
• Pancreatic Cancer
• Pancreatic Neoplasms
• Prostate Cancer
• Stomach Neoplasms

Intervention

Biological:
• CAR-T cell immunotherapy
This CAR-T cell immunotherapy with a novel specific Chimeric antigen receptor aiming at EpCAM antigen.

Locations

Country	Name	City	State
China	IEC of Chengdu Medical College	Chendu

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Chengdu Medical College

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Survival time of anti-EpCAM CAR T cells in vivo	Detect the existence of CAR-T cells in the blood of participants through flow cytometry	up to 24 months	No
Secondary	Anti-tumor efficacy of CAR-T therapy by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1	Anti-tumor efficacy of CAR-T therapy for patients with EpCAM positive cancers was assessed by RECIST v1.1	up to 24 months	No