RecruitingPhase 1NCT06783270

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


Sponsor

Inge Marie Svane

Enrollment

10 participants

Start Date

Dec 16, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new type of personalized cell therapy for advanced melanoma. Researchers remove tumor-fighting immune cells (tumor-infiltrating lymphocytes or TILs) from the patient's own tumor, use CRISPR gene editing to remove a checkpoint (PD-1) that normally suppresses those cells, then infuse the supercharged cells back into the patient. **You may be eligible if...** - You are between 18 and 75 years old - You have inoperable or metastatic melanoma (stage IIIc or IV) - Your cancer progressed after treatment with checkpoint inhibitor drugs (anti-PD-1 with or without anti-CTLA-4) - You have at least one tumor that can be surgically removed to make the TIL product - Your heart and organ function are adequate **You may NOT be eligible if...** - You have not yet tried standard immunotherapy - You have serious autoimmune disease, active infections, or poor organ function - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALTIL 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.


Locations(1)

CCIT-DK

Herlev, Capital Region, Denmark

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NCT06783270


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