RecruitingPhase 1Phase 2NCT03185468
Intervention of Bladder Cancer by CAR-T
Intervention of Advanced or Metastatic Urothelial Bladder Cancer by 4SCAR-T Cell Therapies
Sponsor
Shenzhen Geno-Immune Medical Institute
Enrollment
20 participants
Start Date
Aug 1, 2025
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 18 YearsMax Age: 65 Years
Inclusion Criteria6
- Histologically or cytologically documented locally advanced or metastatic UBC (including renal pelvis, ureters, urinary bladder, and urethra)
- Representative tumor specimens as specified by the protocol
- Adequate hematologic and end organ function
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Life expectancy greater than or equal to (\>/=) 12 weeks
- Measurable disease, as defined by RECIST v1.1
Exclusion Criteria14
- Any approved anti-cancer therapy within 3 weeks prior to initiation of study treatment
- Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days prior to enrollment
- 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
- Leptomeningeal disease
- Malignancies other than UBC within 5 years prior to Cycle 1, Day 1
- Pregnant and lactating women
- Significant cardiovascular disease
- Severe infections within 4 weeks prior to infusion
- Major surgical procedure other than for diagnosis within 4 weeks
- 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
- History of autoimmune disease
- Prior allogeneic stem cell or solid organ transplant
- History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan
- Positive test for human immunodeficiency virus (HIV) and/or active hepatitis B or hepatitis C or tuberculosis
Interventions
GENETIC4SCAR-PSMA
PSMA-specific 4th Generation CART
GENETIC4SCAR-FRa
FRa-specific 4th Generation CART
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT03185468
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