New immune cell therapy for advanced solid tumors that express HER2

Plain-English translation of NCT05681650 on ClinicalTrials.gov ↗ · Source last updated December 2023 · Translation generated September 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 trial is testing a new form of immunotherapy called , which are specially engineered immune cells designed to find and attack cancer cells that have a protein called HER2 on their surface. The cells are engineered with a special feature that helps them survive and work better in the low-oxygen environment inside tumors. This treatment is being tested in people with advanced cancers that haven't responded to standard treatments.

CAR-T cell therapy has worked well against blood cancers, but solid tumors like lung, breast, and gastric cancers are much harder to treat because they create a hostile environment where immune cells struggle to survive and function. This trial exists to see whether the medication can overcome these obstacles by working better in the harsh conditions inside solid tumors.

Do you qualify?

You likely qualify if…

you are between 18 and 75 years old with a life expectancy of at least 3 months
you have been diagnosed with advanced or metastatic solid tumors that have HER2 protein on at least 30% of cancer cells
your cancer has stopped responding to at least one previous standard treatment, or your cancer type has no standard first-line therapy available
you have at least one measurable tumor that can be monitored on imaging
you finished your previous cancer treatment at least 4 weeks before enrolling and have recovered from side effects
you are in good enough overall health to tolerate the treatment (ECOG performance status 0 or 1)

You likely don't qualify if…

you have an active autoimmune disease or condition where your immune system attacks your own body
you have untreated cancer that has spread to your brain, or you are taking high-dose steroids for brain metastases
you are currently taking high-dose steroids (more than 10 mg daily prednisone equivalent) or other immune-suppressing medications
you have a history of severe allergic reactions to monoclonal antibodies or any components of this treatment
you have untreated HIV infection, active serious infections, uncontrolled heart or lung disease, or severe psychiatric conditions that would prevent you from safely participating

What participation looks like

You will receive chemotherapy drugs (, , and ) to prepare your body for the treatment. Then, the engineered immune cells () will be infused into your bloodstream. The trial has two phases: first, doctors will gradually increase the dose to find the safest level, and then additional patients will receive the recommended dose. You will have regular blood tests, imaging scans, and clinic visits to monitor how the treatment is working and manage any side effects.

AI-generated summary from trial data · Sep 11, 2026 · Not medical advice

New immune cell therapy for advanced solid tumors that express HER2

What is this trial?

Do you qualify?

What participation looks like

Trial locations(1 site)