Clinical Trial

Disease: Advanced Stage Epstein-Barr Virus (EBV) Associated Malignancies, (NCT03044743)

Disease info:

Nasopharyngeal (nay-zoh-fuh-RIN-jee-ul) carcinoma is cancer that occurs in the nasopharynx, which is located behind your nose and above the back of your throat. Nasopharyngeal carcinoma is difficult to detect early. That's probably because the nasopharynx isn't easy to examine and symptoms of nasopharyngeal carcinoma mimic those of other, more-common conditions.

Gastric (stomach) cancer occurs when cancer cells form in the lining of the stomach. Risk factors include smoking, infection with H. pylori bacteria, and certain inherited conditions.

Lymphomas are cancers of the lymphatic system and usually originate in the lymph nodes or the spleen and spread through the lymphatic system.

Frequency:
Approximately 0.9 percent of men and women will be diagnosed with stomach cancer at some point during their lifetime, based on 2014-2016 data. Nasopharyngeal cancer is quite rare with less than one case for every 100,000 people.
Official title:
A Phase I/II Trial of PD-1 Knockout EBV-CTLs for Advanced Stage EBV Associated Malignancies
Who:

Contact

Name: Baorui Liu, MD

Phone: 0086-25-83106666-61331

Email: baoruiliu07@163.com


Name: Shu Su, MD

Phone: 0086-25-83106666-61331

Email: ssnine@126.com

Sponsor:

Yang Yang, MD, PhD, MSCR, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Partners:
Locations:

China, Jiangsu

The Comprehensive Cancer Center of Nanjing Drum Tower Hospital, Nanjing, Jiangsu, China, 210008

 

Study start:
Apr. 7, 2017
Enrollment:
20 participants
Gene editing method:
CRISPR-Cas9
Type of edit:
Gene knock-out
Gene:
Programmed cell death protein 1 (PDCD-1)
Delivery method:
Electroporation - Ex-vivo
Note:
Peripheral blood samples were obtained prior to CTL infusion and at pre-determined time points after infusion to evaluate for toxicity and EBV immunity. Clinical response to CTL was assessed by radiographic imaging 8 weeks after the last infusion date
IndicatorIndicator
IND Enabling Pre-clinical
Phase I Safety
Phase II Safety and Dosing
Phase III Safety and Efficacy

Status: Unknown

Description

This study will evaluate the safety of PD-1 knockout EBV-CTL (Epstein Barr Virus-Specific Cytotoxic T Lymphocytes) cells in treating EBV (Epstein-Barr virus) positive advanced stage malignancies. Blood samples will also be collected for research purposes. This is a study of CRISPR-Cas9 mediated PD-1 knockout-T cells from autologous origin. Patients are assigned to receive 4 circles of cell therapy. The safety and clinical response are evaluated. Biomarkers and immunological markers are also monitored.

Last updated: Dec. 28, 2023
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