Intervention of Bladder Cancer by CAR-T

Recruitment & Eligibility

Inclusion Criteria

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 Criteria

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

Study & Design

Arm && Interventions

Group	Intervention	Description
4SCAR-PSMA	4SCAR-PSMA	4SCAR PSMA-modified T cells can recognize and kill tumor cells through the recognize of PSMA .This study will evaluate the side effects and effective doses of 4SCAR-PSMA T cells in treating refractory and recurrent solid tumors.
4SCAR-FRa	4SCAR-FRa	4SCAR FRa-modified T cells can recognize and kill tumor cells through the recognize of FRa .This study will evaluate the side effects and effective doses of 4SCAR-FRa T cells in treating refractory and recurrent solid tumors.

Primary Outcome Measures

Name	Time	Method
Using CTCAE 4 standard to evaluate the level of adverse events after receiving 4SCART infusion	3 months	to evaluate the level of adverse events with CTCAE 4
Overall Survival rate after receiving 4SCART infusion	1 year	to determine the efficacy of 4SCAR T cells

Secondary Outcome Measures

Name	Time	Method
The expansion and persistence of 4SCAR T cells	1 year	The investigators will monitor the expansion and functional persistence of 4SCAR T cells in the peripheral blood of patients and the correlation with antitumor effects
Immune responses after infusions	3 months	assessment of cytokine profile

Recruitment & Eligibility