Actively Recruiting

Phase 1
Phase 2
Age: 18Years - 65Years
All Genders
NCT03185468

Intervention of Bladder Cancer by CAR-T

Led by Shenzhen Geno-Immune Medical Institute · Updated on 2025-09-08

20

Participants Needed

2

Research Sites

230 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Intervention of Bladder Cancer by CAR-T

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically or cytologically confirmed locally advanced or metastatic urothelial bladder cancer (including renal pelvis, ureters, urinary bladder, and urethra)
  • Availability of representative tumor specimens as required by the protocol
  • Adequate blood counts and organ function
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Life expectancy of at least 12 weeks
  • Measurable disease according to RECIST v1.1 criteria
Not Eligible

You will not qualify if you...

  • Received any approved anti-cancer therapy within 3 weeks before study treatment
  • Participated in another clinical trial with therapeutic intent or received investigational agents within 28 days prior to enrollment
  • Active or untreated central nervous system metastases
  • Presence of leptomeningeal disease
  • Other cancers within 5 years prior to the study start
  • Pregnant or breastfeeding women
  • Significant heart disease
  • Severe infections within 4 weeks before infusion
  • Major surgery (other than biopsy) within 4 weeks before infusion
  • History of severe allergic reactions to antibodies or related therapies
  • History of autoimmune diseases
  • Prior allogeneic stem cell or organ transplants
  • History or evidence of certain lung diseases or active pneumonitis
  • Positive for HIV, active hepatitis B or C, or tuberculosis

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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2
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Trial Site Locations

Total: 2 locations

1

Shenzhen Second People Hospital

Shenzhen, Gongdong, China

Actively Recruiting

2

Shenzhen Geno-immune Medical Institute

Shenzhen, Guangdong, China, 518000

Actively Recruiting

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Research Team

L

Lung-Ji Chang, PhD

CONTACT

A

Aifa Tang, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

2

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