A Trial of Personalized Cancer-Fighting Cells for Advanced Solid Tumors

In Plain English

This trial tests a new treatment called IMA203 or IMA203CD8 that uses your own immune cells to fight cancer. Here's how it works: doctors will take some of your white blood cells, send them to a lab where scientists genetically modify them to recognize and attack cancer cells, and then put those enhanced cells back into your body. The goal is to see if this treatment is safe and if it can help people whose cancers have come back or stopped responding to other treatments. Some patients will also receive a drug called nivolumab, which helps your immune system work better. Before you start treatment, you'll need a biopsy (a small tissue sample from your tumor) to check if your cancer has a specific marker called PRAME—think of this like checking if your cancer has the right 'address' for this treatment to find it. You'll also need a blood test to check your HLA type, which is like a cellular barcode that determines if this treatment will work for you. If you're eligible, doctors will collect your white blood cells through a process called leukapheresis (similar to donating blood, but the machine separates out the white cells and returns the rest). Then comes the treatment phase: you'll receive chemotherapy drugs (cyclophosphamide and fludarabine) to prepare your body, followed by an infusion of your modified cells in the hospital. You may also get a low dose of IL-2, a protein that helps your immune cells survive longer. After that, you'll be closely monitored for 5 years.

What This Trial Does

The study's purpose is to establish the safety and tolerability of IMA203/IMA203CD8 products with or without combination with nivolumab in patients with solid tumors that express preferentially expressed antigen in melanoma (PRAME).

How It Works

SCREENING: Patient eligibility will be determined by protocol inclusion/exclusion criteria including HLA (human leukocyte antigen) screening and a biopsy (or collection of archival tumor tissue) for biomarker screening. If the patient is eligible, white blood cells will be taken during leukapheresis for the manufacture of IMA203 or IMA203CD8 product. MANUFACTURING: IMA203 or IMA203CD8 products will be made from the patients' white blood cells. TREATMENT: Lymphodepletion with cyclophosphamide and fludarabine will occur in the days before the IMA203/IMA203CD8 product infusion to improve the duration of time that IMA203/IMA203CD8 product stays in the body. The patient will be admitted to the hospital during the T-cell infusion. After the IMA203/IMA203CD8 product infusion, if applicable, a low dose of IL-2 will be given subcutaneously until day 10. In Extension Cohort B (IMA203) nivolumab will be administered intravenously. Patients will be monitored closely throughout the study. The follow-up phase ends 5 years post infusion.

Who Can Join

Treatments