How far is the clinical trial?

Where does the clinical trial take place?

Disease: Solid Tumors, (NCT05361174)

Q: What is the treatment for?

Read more here 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.

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.

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:

A Phase 1/2, Open-label Study of PD-1 Knockout Tumor-infiltrating Lymphocytes (IOV-4001) in Participants With Unresectable or Metastatic Melanoma or Stage III or IV Non-small-cell Lung Cancer

Who:

Iovance Biotherapeutics Study Team, 866-565-4410, Clinical.Inquiries@iovance.com

Sponsor:

Iovance Biotherapeutics, Inc.

Partners:

Locations:

Not yet disclosed.

Study start:

Jun. 1, 2022

Enrollment:

Gene editing method:

TALEN

Type of edit:

Gene knock-out

Gene:

PDCD1

Delivery method:

Undisclosed - Ex-vivo

Trial link:

https://clinicaltrials.gov/ct2/show/NCT05361174

Safety updates:

(15-03-2022) Iovance Biotherapeutics’ Investigational New Drug Application (IND) Allowed to Proceed for TALEN®-Edited Tumor Infiltrating Lymphocyte (TIL) in Unresectable or Metastatic Melanoma and Stage III or IV Non-Small Cell Lung Cancer (NSCLC)

IND Enabling Pre-clinical

Phase I Safety

Phase II Safety and Dosing

Phase III Safety and Efficacy

Status: Not yet recruiting

Description

This study is the first-in-human study of IOV-4001, a genetically modified autologous tumour-infiltrating lymphocyte (TIL) product. IOV-4001 is expected to exert anti-tumour activity through its capacity to directly target and kill tumour cells in a manner that is similar to non-genome-edited TILs, but with the potential for enhanced anti-tumour activity through disruption of the PDCD1 gene, which encodes programmed cell death protein-1 (PD-1).

Last updated: Jul. 28, 2022

Disease: Solid Tumors, (NCT05361174)

Company