NCT06783270

T-cell Therapy with CRISPR PD1-edited Tumor Infiltrating Lymphocytes for Patients with Metastatic Melanoma

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Inge Marie Svane · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess wether it is safe and feasible to treat patients with tumor infiltrating lymphocytes that have been silenced for PD-1, using CRISPR-Cas9.

Detailed 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.

Conditions

• Melanoma Metastatic

Interventions

Type	Name	Description
BIOLOGICAL	TIL therapy	Compared to traditional TIL-therapy, this study will include silencing of the PD-1 coding gene in the TILs using non-viral CRISPR-Cas9 prior to the rapid expansion protocol.

Timeline

• Start date: 2024-12-16
• Primary completion: 2027-01-01
• Completion: 2028-01-01
• First posted: 2025-01-20
• Last updated: 2025-01-20

Locations

1 site across 1 country: Denmark