Recruiting

Testing genetically modified immune cells for advanced melanoma and lung cancer

Plain-English translation of NCT05361174 on ClinicalTrials.gov ↗ · Source last updated June 2026 · 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 is the first human study of , a treatment made from your own immune cells that have been specially modified in the laboratory. Researchers have removed a gene that normally tells immune cells to stop fighting, with the goal of helping these cells attack cancer more effectively. The study will test whether this modified treatment is safe and whether it can shrink melanoma or non-small-cell lung cancer that hasn't responded to other standard treatments.

Some patients with advanced melanoma or lung cancer stop responding to current immunotherapy drugs, and their cancer continues to grow. This medication explores a new approach by genetically enhancing immune cells to potentially overcome the mechanisms that allow cancer to hide from the body's defenses.

Do you qualify?

You likely qualify if…

you have been diagnosed with advanced melanoma that cannot be surgically removed or has spread, or with stage III or IV non-small-cell lung cancer
your cancer has gotten worse within 12 weeks after receiving immunotherapy drugs (anti-PD-1/PD-L1 treatments), and you may have had other prior treatments depending on your cancer type
you are in good enough overall health to tolerate the treatment, as measured by a standard performance status test
you have at least one tumor that can be surgically removed to create the treatment, and at least one other measurable tumor remaining
your heart, lungs, and other organs are functioning adequately to handle this treatment
if you can have children or have a partner who can, you are willing to use highly effective birth control during treatment and for 12 months after

You likely don't qualify if…

you have eye melanoma (uveal or ocular melanoma)
you have untreated brain tumors that are causing symptoms
you have received a stem cell or bone marrow transplant, or certain types of previous cell therapy
you currently need high-dose steroids (10 mg or more of prednisone daily) for another condition
you have a primary immune system disorder or another active cancer diagnosed within the past 3 years

What participation looks like

If you qualify and enroll, a surgeon will first remove one of your tumors, which is then sent to the laboratory to grow and modify your immune cells over several weeks. Once the modified cells are ready, you will receive them back as an infusion into your body. You will have regular follow-up visits and tests to monitor how well the treatment is working and watch for any side effects. The study involves two groups: one focusing on melanoma and one on lung cancer.

AI-generated summary from trial data · Jun 18, 2026 · Not medical advice

Trial locations(11 sites)

United States

The Angeles Clinic and Research Institute, Los Angeles, California

Sylvester Comprehensive Cancer Center, Miami, Florida

Orlando Health Cancer Institute, Orlando, Florida

Moffitt Cancer Center, Tampa, Florida

The University of Kansas Cancer Center, Westwood, Kansas