CRISPR-Enhanced TILs for Melanoma
CRISPR gene-edited TIL therapy trial for metastatic melanoma. Revolutionary gene editing technology to enhance immune cells.
A Phase I Study of CRISPR-Enhanced Tumor-Infiltrating Lymphocytes (TILs) in Melanoma
Full Title
A phase I, open-label, dose-escalation study of CRISPR-Cas9 gene-edited tumor-infiltrating lymphocytes with enhanced anti-tumor function in patients with metastatic melanoma
Purpose
Scientists take immune cells from your tumor, use CRISPR gene editing to make them better at fighting cancer, grow billions of these enhanced cells in the lab, then give them back to you. The gene editing removes the “brakes” that stop immune cells from attacking cancer effectively.
Primary Objectives
- Determine safety and maximum tolerated dose of CRISPR-enhanced TIL therapy
- Evaluate feasibility of CRISPR gene editing in patient-derived TILs
- Assess TIL persistence, trafficking, and anti-tumor function after gene editing
Diseases
- Metastatic Melanoma
- Advanced Melanoma
- Cutaneous Melanoma
Who Can Join this Trial
To participate in this study, you must meet ALL of the following criteria
- Have histologically confirmed metastatic melanoma with measurable disease
- Have progressive disease following at least one line of immune checkpoint inhibitor therapy
- Have accessible tumor lesions suitable for surgical resection to obtain TILs
- Successful TIL outgrowth from tumor specimen during screening period
- ECOG performance status 0-1
- Age 18-70 years
- Life expectancy ≥16 weeks
- Adequate organ function for high-dose interleukin-2 therapy
- Normal cardiac and pulmonary function
- No active autoimmune disease or requirement for chronic immunosuppression
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Locations
CONTACT
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