A Clinical Research of CAR T Cells Targeting EpCAM Positive Cancer

NCT ID: NCT03013712

Last Updated: 2017-01-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2020-12-31

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.

Detailed 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.

Conditions

Colon Cancer; Esophageal Carcinoma; Pancreatic Cancer; Prostate Cancer; Gastric Cancer; Hepatic Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

CAR-T cell immunotherapy

Intervention Type: BIOLOGICAL

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

Interventions

CAR-T cell immunotherapy

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

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Affiliated Hospital of Chengdu Medical College

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xiao-an Li, PhD

Role: STUDY_CHAIR

First Affiliated Hospital of Chengdu Medical College

Locations

IEC of Chengdu Medical College

Chendu, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Yan Zhou, PhD

Role: CONTACT

zqlvzy319@163.com

+86-18981941992

Facility Contacts

Xiao-an Li, post doctor

Role: primary

435445611@qq.com

+8613680868858

Other Identifiers

CARTEPC-001

Identifier Type: -

Identifier Source: org_study_id