Brief Title: Intervention of Bladder Cancer by CAR-T

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Overall Survival rate after receiving 4SCART infusion

Primary Outcome 1 - Timeframe: 1 year

Primary Outcome 2 - Measure: Using CTCAE 4 standard to evaluate the level of adverse events after receiving 4SCART infusion

Primary Outcome 2 - Timeframe: 3 months

CONDITION

• Bladder Cancer
• Urothelial Carcinoma Bladder

ELIGIBILITY

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Lung-Ji Chang, PhD

Role: Principal Investigator

Affiliation: Shenzhen Geno-Immune Medical Institute

Overall Contact

Name: Lung-Ji Chang, PhD, Aifa Tang, PhD

Phone: 86-13671121909

Email: [email protected], [email protected]

LOCATION