Disease: Solid Tumor Adult, (NCT03747965)

Disease info:

An abnormal mass of tissue that usually does not contain cysts or liquid areas. Solid tumours may be benign (not cancer), or malignant (cancer). Different types of solid tumours are named for the type of cells that form them. Examples of solid tumours are sarcomas, carcinomas, and lymphomas. Leukemias (cancers of the blood) generally do not form solid tumours.

Frequency:
Based on projections, cancer deaths will continue to rise with an estimated 9 million people dying from cancer in 2015, and 11.4 million dying in 2030.
Official title:
Phase I Study of CRISPR-Cas9 Mediated PD-1 Gene-knocked Out Mesothelin-directed CAR-T Cells With the Conditioning Regimen of Paclitaxel and Cyclophosphamide in Mesothelin Positive Multiple Solid Tumors
Who:

Study Director: Weidong Han, Dr. Chinese PLA General Hospital

Sponsor:

Chinese PLA General Hospital

Partners:
Locations:

China, Beijing

Study start:
Nov. 1, 2018
Enrollment:
10 participants
Gene editing method:
CRISPR-Cas9
Gene:
PDCD1 Programmed cell death protein 1
Delivery method:
Lentiviral vector - Ex-vivo
Indicator
IND Enabling Pre-clinical
Phase I Safety
Phase II Safety and Dosing
Phase III Safety and Efficacy

Status: Active recruiting

Description

Multiple solid tumors have positive targets of mesothelin expressed on the surfaces of the tumor cells, the investigators use the technique of CRISPR-Cas9 to knocked out the PD-1 of the chimeric antigen receptor (CAR) T cells with the combination of Pretreatment by Paclitaxel and Cyclophosphamideto to effect the immuno-microenvironment around tumors.

  1. To evaluate the feasibility and safety of CRISPR-Cas9 mediated PD-1 gene-knocked out chimeric antigen receptor (CAR) T cells in patients with mesothelin positive multiple solid tumors.
  2. To evaluate the duration and in vivo persistence of transferred CAR-T cells.
  3. To observe and measure anti-tumor responses for patients with detectable mesothelin positive tumor lesions.
Last updated: Aug. 1, 2020
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