Clinical Trial

Disease: Engineered TILs/CAR-TILs to Treat Advanced Solid Tumors (NCT04842812)

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. 

A tumour-infiltrating lymphocyte (TIL) is a type of immune cell that has moved from the blood into a tumour. TILs can recognise and kill cancer cells. In cancer therapy, tumour-infiltrating lymphocytes are removed from a patient’s tumour, grown in large numbers in a laboratory, and then given back to the patient to help the immune system kill the cancer cells. 

 

Frequency:
Based on projections, cancer deaths will continue to rise with an estimated 11.4 million cancer-related deaths per year in 2030.
Official title:
Engineered TILs/CAR-TILs With PD1 Knockout and Anti-PD1/CTLA4-scFv Secreting or CARs Against Various Antigens to Treat Advanced Solid Tumors
Who:

 

Principal Investigator:Zhenfeng Zhang, MD, PhD. Second Affiliated Hospital of Guangzhou Medical University

Sponsor:

Second Affiliated Hospital of Guangzhou Medical University

Partners:

Guangdong Zhaotai InVivo Biomedicine Co. Ltd.

Locations:

China, Guangzhou

Study start:
Jan. 1, 2021
Enrollment:
40
Gene editing method:
CRISPR-Cas9
Type of edit:
Gene knock-out
Gene:
Programmed Cell Death 1 (PD-1)
Delivery method:
- Ex-vivo
Trial link:
https://clinicaltrials.gov/ct2/show/record/NCT04842812
Other links:

LinkSolid tumors Disease informationLinkAssessing tumor infiltrating lymphocytes in solid tumors: a practical review for pathologists and proposal for a standardized method from the International Immuno-Oncology Biomarkers Working Group

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

Status: Active recruiting

Description

Therapeutic tumour-infiltrating lymphocytes (TILs) generally refers to a preparation of cells that are manipulated in vitro and, upon administration in vivo, re-infiltrate the tumour to initiate tumour cell lysis. In vitro, TILs are isolated from tumour tissue and cultured with lymphokines such as interleukin-2; the therapeutic TILs are then infused into the patient, where, after re-infiltration of the tumour, they may induce lysis of tumour cells and promote tumour regression. The use of therapeutic TILs is considered a form of adoptive immunotherapy.

In this trial, the safety, tolerance, and preliminary clinical efficacy of TILs will be evaluated. In this case, TILs will be harvested from cancer patients with advanced disease, and subjected to PD1 gene knockout using CRISPR-Cas9 technology. They will also be engineered to express scFvs against both PD1 and CTALA4 and CARs against various antigens, before their re-transfusion into the patients.

Last updated: Apr. 8, 2022
Source: US National Institutes of Health (NIH)
clinicaltrials.gov
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