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

INTRODUCTION

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

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.

  • Overall Status
    Unknown status
  • Start Date
    May 15, 2017
  • Phase
    Phase 1, Phase 2
  • Study Type
    Interventional

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:
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

Gender: All

Minimum Age: 18 Years

Maximum Age: 65 Years

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

Phone: 86-13671121909

Email: c@szgimi.org, tangaifa2004@163.com

LOCATION

Facility Status Contact