Clinical Trial

Disease: 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. 

The word tumor does not always imply cancer. In discussing tumors that are malignant (cancerous), however, the term solid tumor is used to distinguish between a localized mass of tissue and leukemia.

More than 1.9 million new cancer cases are expected to be diagnosed in the US in 2023.
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


Name: Zhenfeng Zhang, MD, PhD

Phone: +862039195966


Name: Bingjia He, MD

Phone: +862039195965



Guangdong Zhaotai InVivo Biomedicine Co. Ltd.


China, Guangzhou

Study start:
Jan. 1, 2021
Gene editing method:
Type of edit:
Gene knock-out
Programmed Cell Death 1 (PD-1)
Delivery method:
Electroporation - Ex-vivo
IND Enabling Pre-clinical
Phase I Safety
Phase II Safety and Dosing
Phase III Safety and Efficacy

Status: Active recruiting


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.

A 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.

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: Dec. 28, 2023
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