Engineered immune cells take aim at Hard-to-Treat cancers
NCT ID NCT07487597
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new treatment called Enhanced ALPP CAR-T cells for people with advanced solid tumors that have not responded to standard therapies. The treatment involves taking a patient's own immune cells, modifying them in a lab to recognize and attack cancer cells that have a specific marker (ALPP), and then infusing them back. The main goals are to find a safe dose and see if the cells can shrink tumors.
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
-
Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
-
About 24 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Feb 2026
- Expected to finish
-
Feb 2029
An estimate. End dates often move.
- Lead sponsor
-
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
-
18 to 70 years
- Sex
-
Anyone
- Healthy volunteers
-
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: 1. Participants must voluntarily provide written informed consent. 2. Aged 18-70 years (inclusive). 3. Life expectancy ≥ 3 months. 4. ECOG performance status 0-1. 5. Failed or unsuitable for standard therapy. 6. At least one measurable lesion per RECIST 1.1. 7. ALPP-positive tumor confirmed by immunohistochemistry. 8. Adequate organ and bone marrow function. 9. Effective contraception required for participants of childbearing potential. 10. Adequate venous access for leukapheresis. Exclusion Criteria: 1. Primary CNS malignancy or uncontrolled CNS metastases. 2. Other malignancies within 5 years (except adequately treated non-melanoma skin cancer or carcinoma in situ). 3. Active autoimmune disease or history of autoimmune disease. 4. Immunodeficiency, including HIV positivity. 5. Bleeding disorders (inherited or acquired). 6. Clinically significant cardiovascular disease. 7. Active infection (including tuberculosis, hepatitis B/C, syphilis). 8. Pregnant or breastfeeding women. 9. History of refractory epilepsy, active GI bleeding, or high risk of tumor bleeding. 10. Severe systemic or psychiatric illness. 11. Prior cell or gene therapy. 12. Severe drug hypersensitivity history. 13. Investigator-assessed unsuitability for trial participation.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Advanced solid tumor are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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
-
The Jinling Hospital
RECRUITINGNanjing, Jiangsu, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- First human test of BI 4060107 aims to find safe dose for Hard-to-Treat tumors
- First-in-Human trial asks whether HG381 is safe and tolerable in advanced solid tumors
- Custom-Built immune cells take aim at a notorious cancer mutation
- Can a new drug shield kidneys from chemotherapy damage?
- Experimental injection SHR-7787 put to the test against advanced solid tumors
- Experimental biologic AWT020 put to the test in Hard-to-Treat cancers