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Recruiting

NCT Number: NCT03185468

Intervention of Bladder Cancer by CAR-T

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.

Recruiting

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Shenzhen Geno-immune Medical Institute

Shenzhen, Guangdong, 518000, China

Location status: Recruiting

Location contact

Lung-Ji Chang, PhD

CONTACT

[email protected]

86-13671121909

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

4SCAR-PSMA

Genetic

PSMA-specific 4th Generation CART

4SCAR-FRa

Genetic

FRa-specific 4th Generation CART

Primary outcomes

  1. Overall Survival rate after receiving 4SCART infusion

    Time frame: 1 year

    to determine the efficacy of 4SCAR T cells

  2. Using CTCAE 4 standard to evaluate the level of adverse events after receiving 4SCART infusion

    Time frame: 3 months

    to evaluate the level of adverse events with CTCAE 4

Secondary outcomes

  1. The expansion and persistence of 4SCAR T cells

    Time frame: 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

  2. Immune responses after infusions

    Time frame: 3 months

    assessment of cytokine profile

Study contacts

Contact information is provided by the study sponsor or research team.

Lung-Ji Chang, PhD

CONTACT

[email protected]

86-13671121909

Sponsors and collaborators

Lead sponsor

Shenzhen Geno-Immune Medical Institute

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Jun 14, 2017
Registry last updated
Jun 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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