Experimental CAR-T therapy targets Hard-to-Treat solid tumors
NCT ID NCT04627740
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This pilot study tested a new type of immune cell therapy called anti-ALPP CAR-T cells in 5 patients with advanced solid tumors that have a specific marker (ALPP). The goal was to see if the treatment is safe and can shrink tumors. Patients first received chemotherapy to prepare their bodies, then the modified immune cells were infused. The study is complete, but results are not yet widely reported.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Anti-ALPP CAR-T cells (a type of immune cell therapy)
- What this could lead to
- If it works, this could point toward a new treatment option for certain advanced solid tumors that express ALPP.
- What could go wrong
- This is a very early, small study with only 5 participants, so results may not apply to larger groups. CAR-T therapy can cause serious side effects like cytokine release syndrome.
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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5 people
The number who actually took part.
- Started
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Dec 2020
- Finished
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Aug 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
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 70 years
- Sex
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Female participants only
- 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: * Expected to survive more than 3 months * PS 0-2 * Immunohistochemistry was confirmed to be mesothelin positive ALPP (higher than 50%) * Patients with no curative regimen to receive * WBC\>3.5×1e+9/L,Hb\>90g/L,PLT\>75×1e+9/L * HBV DNA copy number less than 100/ml * ALT≤5ULN, AST≤5ULN, TB≤1.5ULN, ALB≥35g/L * Understand this test and have signed informed consent Exclusion Criteria: * Autoimmune diseases, or any uncontrolled active disease that hinders participation in the trial * Decompensated liver cirrhosis, liver function Child-pugh C grade * Portal vein tumor thrombus, arterial portal fistula, hepatic arteriovenous * Long-term use of immunosuppressive agents after organ transplantation * Screening indicated that the target cell transfection rate was less than 30% * Invasive pulmonary embolism, deep venous thrombosis, or other major arterial / venous thromboembolic events occurred 30 days or 30 days prior to randomization * Subjects had an active or uncontrollable infection requiring systemic therapy 14 days or 14 days prior to randomization * Pregnant or lactating subjects * In the opinion of the investigator, the presence of a medical history or a history of mental state may increase the number of subjects associated with the risk factors associated with the study or study drug administration * Subjects who have signed a written consent or who are in compliance with the study procedure; or who are unwilling or unable to comply with the study
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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.
Contacts and locations
Locations
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Department of Oncology, Xinqiao Hospital
Chongqing, Chongqing Municipality, 400037, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- 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
- Experimental injection SHR-7787 put to the test against advanced solid tumors
- Experimental biologic AWT020 put to the test in Hard-to-Treat cancers
- Can a pill shrink Hard-to-Treat ovarian tumors?
- Oral drug RVU120 put to the test against advanced solid tumors