Recruiting

Engineered immune cells to treat advanced cancers

Plain-English translation of NCT05296564 on ClinicalTrials.gov ↗ · Source last updated October 2025 · Translation generated June 2026 · How we translate trials

Phase 1/2 — A combined trial that checks safety and dosing while also starting to look at whether the treatment works.

What is this trial?

This study is testing a new treatment called , which uses your own immune cells that have been genetically engineered in a laboratory to recognize and attack cancer cells. Researchers remove white blood cells from your body, reprogram them to target a protein found on certain cancers, and then infuse them back into you. The goal is to see if this approach is safe and whether it can shrink tumors.

Many advanced cancers are difficult to treat with standard therapies, and patients may not respond well to existing treatments. This medication represents a newer approach that harnesses your own immune system to fight cancer more effectively by training your cells to recognize cancer-specific targets.

Do you qualify?

You likely qualify if…

you have been diagnosed with metastatic (advanced) cancer or locally advanced cancer that has a specific protein called NY-ESO-1
your cancer has either not responded to standard treatments, come back after treatment, or you cannot tolerate standard therapies
you are between 18 and 70 years old
you have a specific genetic marker (HLA-A*0201 or A*0206) that allows this treatment to work
you have adequate organ function (healthy blood counts, liver, and kidney function)
you are willing to use birth control for at least four months after treatment

You likely don't qualify if…

you are pregnant, breastfeeding, or unwilling to use birth control
you have a weakened immune system or primary immunodeficiency disorder
you have an active infection requiring antibiotics or other serious untreated medical conditions
you have HIV, hepatitis B, or hepatitis C
you received chemotherapy or other systemic cancer treatment less than four weeks before starting this study

What participation looks like

The trial has two parts. In Part A, a small group of patients receives increasing doses of the engineered cells to find the safest dose. In Part B, more patients receive the selected safe dose to see if the treatment actually works. You will have blood drawn so your cells can be engineered in the laboratory, receive a preparative regimen (chemotherapy to prepare your body), and then receive infusions of your re-engineered cells. You will be closely monitored for safety and your tumors will be measured to see if they shrink.

AI-generated summary from trial data · Jun 9, 2026 · Not medical advice

Trial locations(1 site)

Israel

Hadassah Medical Organization, Jerusalem