Engineered immune cells take aim at Hard-to-Treat cancers
NCT ID NCT07510828
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new treatment using donor immune cells (CAR-NK cells) that are engineered to recognize and attack cancer. The treatment is personalized based on a tumor's unique markers. It is for adults with advanced solid tumors that have not responded to other therapies. The goal is to see if it is safe and shows signs of shrinking tumors.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- CAR-NK cells (immune cells from a donor engineered to target cancer)
- What this could lead to
- If it works, this could point toward a new treatment option for people with advanced solid tumors that have stopped responding to standard therapies.
- What could go wrong
- This is an early-phase trial with only 60 participants, so the treatment may not work or could cause serious side effects. The approach is complex and may not be widely available.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2026
- Expected to finish
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Apr 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age 18 to 75 years at the time of consent. * Histologically or cytologically confirmed advanced or metastatic solid tumor that is refractory to, relapsed after, or intolerant of standard therapy, or for which no standard therapy exists. * At least 1 measurable lesion per RECIST v1.1. * Tumor antigen positivity documented by tissue biopsy and/or liquid biopsy using a protocol-specified assay; for dual-target cohort: co-expression of both antigens above threshold. * ECOG performance status 0-1. * Adequate organ function (hematologic, renal, hepatic) as defined by protocol labs. * Ability to undergo lymphodepleting chemotherapy (if required) and receive IV cell infusion. * Negative pregnancy test for individuals of childbearing potential; agreement to use effective contraception during study participation and for a protocol-defined period after infusion. * Willingness to provide baseline blood samples and, when feasible, tumor biopsy for biomarker analyses. Exclusion Criteria: * Active, uncontrolled infection, including uncontrolled bacterial, fungal, or viral infection. * Known uncontrolled HIV infection; active hepatitis B or hepatitis C with evidence of active replication (per local testing). * Clinically significant cardiovascular disease (e.g., recent myocardial infarction, uncontrolled arrhythmia) that would increase risk from lymphodepletion or infusion. * Active central nervous system (CNS) metastases that are symptomatic or require escalating steroids. (Stable treated CNS disease may be allowed per protocol.) * Current systemic immunosuppressive therapy (e.g., \>10 mg/day prednisone equivalent) within a protocol-defined window prior to lymphodepletion. * Prior gene-modified cellular therapy within 3 months or any prior therapy that, in the investigator's judgment, would confound safety evaluation. * Prior allogeneic hematopoietic stem cell transplant within 6 months, or active graft-versus-host disease. * Pregnant or breastfeeding. * Any condition that, in the investigator's opinion, would interfere with study participation, compliance, or interpretation of results.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Peking University Shenzhen Hospital
RECRUITINGShenzhen, Guangdong, 518036, China
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- Can a dual protein blocker shrink Hard-to-Treat tumors?
- Can a new biologic boost the immune System's fight against advanced tumors?
- Experimental pill SHY-ONC6 takes on Hard-to-Treat cancers