Clinical Trial

Disease: Solid Tumor Adult, (NCT03545815)

Disease info:

A solid tumour is an abnormal mass of tissue that usually does not contain cysts or liquid areas. Solid tumours may be benign (not cancer), or malignant (cancer). Solid tumour types are named according to the type of cell they originate from. Examples of solid tumours are sarcomas, carcinomas, and lymphomas. Leukaemias (cancers of the blood) generally do not form solid tumours.

The word tumour does not always imply cancer. In discussing tumours that are malignant (cancerous), however, the term solid tumour is used to distinguish between a localised mass of tissue and leukaemia.

 

 

 

 

Frequency:
Excluding non-melanoma skin cancers, over 2 million new cancer cases are expected to be diagnosed in the US in 2025.
Official title:
Phase I Study to Evaluate Treatment of CRISPR-Cas9 Mediated PD-1 and TCR Gene-knocked Out Chimeric Antigen Receptor (CAR) T Cells in Patients With Mesothelin Positive Multiple Solid Tumors.
Who:

Contact

Name: Han Weidong

Phone: 86-10-13651392893

Email: hanwdrsw@sina.com

Sponsor:

Chinese PLA General Hospital

Partners:
Locations:

China, Beijing

Biotherapeutic Department and Hematology Department of Chinese PLA General Hospital, Beijing, China, 100853

Study start:
Mar. 19, 2018
Enrollment:
10 participants
Gene editing method:
CRISPR-Cas9
Type of edit:
Gene knock-out
Gene:
Programmed cell death protein 1 (PDCD1, or PD-1) and T Cell Receptor (TCR)
Delivery method:
Electroporation and lentiviral transduction (LV) - Ex-vivo
Trial link:
https://clinicaltrials.gov/ct2/show/record/NCT03545815
Safety updates:

(11-08-2021) Phase I study of CAR-T cells with PD-1 and TCR disruption in mesothelin-positive solid tumors

Other links:

LinkSolid tumors definitionLinkSolid tumors frequencyLinkThe Role of Gene Editing Within CAR T-Cell Therapy Development - Interview with Professor Waseem Qasim

Indicator
IND Enabling Pre-clinical
Phase I Safety
Phase II Safety and Dosing
Phase III Safety and Efficacy

Status: Unknown

Description

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

  1. To evaluate the feasibility and safety of CRISPR-Cas9 mediated PD-1 and TCR gene-knocked out chimeric antigen receptor (CAR) T cells in patients with mesothelin positive multiple solid tumors.
  2. To evaluate the duration of 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: Feb. 24, 2025
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