Clinical Trial

Disease: Metastatic Melanoma, (NCT06783270)

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 include melanomas, sarcomas, carcinomas and lymphomas. 

This trial is specifically targeting patients with advanced or metastatic (progressive) melanoma. Melanoma is a rare form of skin cancer.

 

Frequency:
The American Cancer Society estimates that in 2025, about 104,960 new melanoma cases will be diagnosed in the United States, and approximately 8,430 people are expected to die from the disease.
Official title:
T-cell Therapy with CRISPR PD1-edited Tumor Infiltrating Lymphocytes for Patients with Metastatic Melanoma
Who:

Contact 

Name: Joel E Sohlin, MD

Phone: +4538689198

Email: joel.emanuel.sohlin@regionh.dk

 

Name: Inge Marie Svane, MD, phd, prof

Phone: +4538682131

Email: inge.marie.svane@regionh.dk

Sponsor:

Inge Marie Svane

Partners:

Herlev Hospital

Locations:

Capital region, Denmark

Herlev, Capital region, Denmark, 2730

Study start:
Dec. 16, 2024
Enrollment:
10 participants
Gene editing method:
CRISPR-Cas9
Type of edit:
Gene silence
Gene:
PD-1
Delivery method:
Electroporation - Ex-vivo
Trial link:
https://clinicaltrials.gov/study/NCT06783270
Safety updates:

(10-01-2022) Highly efficient PD-1-targeted CRISPR-Cas9 for tumor-infiltrating lymphocyte-based adoptive T cell therapy

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

Status: Active recruiting

Description

In this study the investigators will treat patients with advanced (inoperable) or metastatic melanoma with tumor infiltrating lymphocytes (TILs) in combination with lymphodepleting chemotherapy and high-dose interleukin-2. The TILs are harvested from a patient tumor and expanded a thousand-fold in a laboratory over approximately 6 weeks before being infused back into the patient. This is a well known and tried treatment regimen, often called TIL-therapy or TIL-ACT. In this study the investigators will add CRISPR-Cas9 modification to the production process of the TILs to silence the expression of PD-1 on the surface of the infused cells. The aim of this study is to demonstrate wether treatment with these PD1-deficient TILs (CRISPR-TILs) is safe and feasible.

Last updated: Feb. 13, 2025
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