Recruiting

Testing a new vaccine combined with immunotherapy for advanced cancers

Plain-English translation of NCT05631886 on ClinicalTrials.gov ↗ · Source last updated August 2023 · Translation generated August 2026 · How we translate trials

Phase 1 — Testing in a small group (usually 20–80 people) to find a safe dose and watch for side effects.

What is this trial?

This trial is testing a combination treatment for advanced cancers that have not responded to standard therapy. The main treatment is called vaccine — a personalized vaccine made from your own dendritic cells (immune cells that fight disease) that are engineered in the laboratory to target cancer cells. This medication is given alongside two immune-boosting antibody drugs (anti-PD-1 and anti-CTLA4) to help your immune system attack the cancer more effectively.

Standard cancer treatments often stop working, and existing cancer vaccines haven't been very effective on their own. Researchers believe that combining a personalized dendritic cell vaccine with immune checkpoint inhibitor medications may unlock your immune system's ability to recognize and destroy cancer cells that have specific genetic changes (TP53 mutations).

Do you qualify?

You likely qualify if…

you are between 18 and 75 years old
you have advanced or metastatic solid tumors or lymphomas that have either not responded to standard treatment or relapsed after at least 2 previous treatment lines
your cancer cells are confirmed to have specific genetic changes (TP53 mutations: R273H, R175H, R248Q, or R249S) and express a protein marker called EphA2
you have at least one measurable tumor lesion that can be tracked on scans
your organ function (kidneys, liver, bone marrow) is adequate as measured by blood tests
you are willing to have a tumor biopsy or tissue sample taken for testing

You likely don't qualify if…

you have an inherited (germline) TP53 mutation
you have untreated cancer in your brain or active brain involvement
you have had an organ transplant or stem cell transplant
you have an active viral, bacterial, or fungal infection
you are HIV-positive or have active hepatitis B or C

What participation looks like

You would first receive conditioning chemotherapy (two drugs given 3 days before the vaccine). Then you receive the personalized vaccine on days 0 and 7 of week 1. Starting in week 5, you receive the vaccine once every 8 weeks, along with the two immune-boosting antibody medications given every 3 weeks for four doses, then one of the antibodies continues every 3 weeks. Treatment continues until your disease progresses, unacceptable side effects occur, or your immune response to the vaccine is no longer detectable. Throughout the trial, you will have regular clinic visits for blood tests, imaging scans, and checkups to monitor your response and side effects.

AI-generated summary from trial data · Aug 5, 2026 · Not medical advice

Trial locations(1 site)

China

Biotherapeutic Department of Chinsese PLA Gereral Hospital, Beijing, Beijing Municipality