Engineered immune cells take on bladder cancer in early trial
NCT ID NCT03185468
First seen Jun 25, 2026 · Last updated Aug 25, 2026 · Updated 3 times
Summary
This early-stage trial tests a new type of immunotherapy called 4SCAR-T cells in 20 people with advanced bladder cancer that has spread and no longer responds to standard treatments. The cells are genetically modified to recognize and attack cancer cells. The study aims to see if this approach is safe and can help patients live longer.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- 4SCAR-T cells (genetically modified immune cells targeting PSMA and FRa proteins)
- What this could lead to
- If it works, this could point toward a new treatment option for advanced bladder cancer when other therapies have failed.
- What could go wrong
- This is a very early Phase I/II trial with only 20 participants, so results may not apply broadly. Cell therapies can cause severe 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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20 people
The number who actually took part.
- Started
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Aug 2025
- Finished
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Jul 2026
- 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 65 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.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Histologically or cytologically documented locally advanced or metastatic UBC (including renal pelvis, ureters, urinary bladder, and urethra) 2. Representative tumor specimens as specified by the protocol 3. Adequate hematologic and end organ function 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 5. Life expectancy greater than or equal to (\>/=) 12 weeks 6. Measurable disease, as defined by RECIST v1.1 Exclusion Criteria: 1. Any approved anti-cancer therapy within 3 weeks prior to initiation of study treatment 2. Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days prior to enrollment 3. Active or untreated central nervous system (CNS) metastases as determined by computed tomography (CT) or magnetic resonance imaging (MRI) evaluation during screening and prior radiographic assessments 4. Leptomeningeal disease 5. Malignancies other than UBC within 5 years prior to Cycle 1, Day 1 6. Pregnant and lactating women 7. Significant cardiovascular disease 8. Severe infections within 4 weeks prior to infusion 9. Major surgical procedure other than for diagnosis within 4 weeks 10. History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins; known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the atezolizumab formulation 11. History of autoimmune disease 12. Prior allogeneic stem cell or solid organ transplant 13. History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan 14. Positive test for human immunodeficiency virus (HIV) and/or active hepatitis B or hepatitis C or tuberculosis
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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
-
Shenzhen Geno-immune Medical Institute
Shenzhen, Guangdong, 518000, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Dutch bladder cancer cohort aims to map survival and recurrence
- Can two drugs plus chemoradiation let bladder cancer patients keep their bladder?
- Lab-Grown tumor organoids could pick the right bladder chemo
- Can tumor genes decide who keeps their bladder?
- Lab-Grown tumor models could match patients to the right cancer drug
- Can heated saline during bladder surgery stop tumors from coming back?