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)

Shenzhen Second People Hospital

Shenzhen, Gongdong, China

Shenzhen Geno-immune Medical Institute

Shenzhen, Guangdong, China

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NCT03185468


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