NCT03185468 Intervention of Bladder Cancer by CAR-T
| NCT ID | NCT03185468 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Shenzhen Geno-Immune Medical Institute |
| Condition | Bladder Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-08-01 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 20 participants in total. It began in 2025-08-01 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a Phase I/II and multicenter study designed to evaluate the efficacy and safety of 4SCAR-T cells in participants with locally advanced or metastatic urothelial bladder cancer (UBC) who have no further treatment available.
Eligibility Criteria
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
Contact & Investigator
Lung-Ji Chang, PhD
PRINCIPAL INVESTIGATOR
Shenzhen Geno-Immune Medical Institute
Frequently Asked Questions
Who can join the NCT03185468 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Bladder Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03185468 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT03185468 currently recruiting?
Yes, NCT03185468 is actively recruiting participants. Contact the research team at c@szgimi.org for enrollment information.
Where is the NCT03185468 trial being conducted?
This trial is being conducted at Shenzhen, China, Shenzhen, China.
Who is sponsoring the NCT03185468 clinical trial?
NCT03185468 is sponsored by Shenzhen Geno-Immune Medical Institute. The principal investigator is Lung-Ji Chang, PhD at Shenzhen Geno-Immune Medical Institute. The trial plans to enroll 20 participants.
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