Intervention of Advanced or Metastatic Urothelial Bladder Cancer by 4SCAR-T Cell Therapies


  • Org Study ID: GIMI-IRB-17004
  • Secondary ID: N/A
  • NCT ID: NCT03185468
  • Sponsor: Shenzhen Geno-Immune Medical Institute


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.

  • Overall Status
    Unknown status
  • Start Date
    May 15, 2017
  • Phase
  • Study Type


Primary Outcome 1 - Measure:

Primary Outcome 1 - Timeframe: N/A


  • Bladder Cancer
  • Urothelial Carcinoma Bladder


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


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



Facility Status Contact