Intervention of Bladder Cancer by CAR-T

September 4, 2025 updated by: Lung-Ji Chang, Shenzhen Geno-Immune Medical Institute

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Lung-Ji Chang, PhD
  • Phone Number: 86-13671121909
  • Email: c@szgimi.org

Study Locations

  • China
    • Gongdong
      • Shenzhen, Gongdong, China
    • Guangdong
      • Shenzhen, Guangdong, China, 518000
        • Recruiting
        • Shenzhen Geno-immune Medical Institute
        • Contact:
          • Lung-Ji Chang, PhD
          • Phone Number: 86-13671121909
          • Email: c@szgimi.org

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 4SCAR-PSMA
4SCAR PSMA-modified T cells can recognize and kill tumor cells through the recognize of PSMA .This study will evaluate the side effects and effective doses of 4SCAR-PSMA T cells in treating refractory and recurrent solid tumors.
Genetic: 4SCAR-PSMA
PSMA-specific 4th Generation CART
Experimental: 4SCAR-FRa
4SCAR FRa-modified T cells can recognize and kill tumor cells through the recognize of FRa .This study will evaluate the side effects and effective doses of 4SCAR-FRa T cells in treating refractory and recurrent solid tumors.
Genetic: 4SCAR-FRa
FRa-specific 4th Generation CART

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival rate after receiving 4SCART infusion
Time Frame: 1 year
to determine the efficacy of 4SCAR T cells
1 year
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
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 year
Immune responses after infusions
Time Frame: 3 months
assessment of cytokine profile
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shenzhen Geno-Immune Medical Institute

Investigators

  • Principal Investigator: Lung-Ji Chang, PhD, Shenzhen Geno-immune Medical Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2025

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2029

Study Registration Dates

First Submitted

June 10, 2017

First Submitted That Met QC Criteria

June 10, 2017

First Posted (Actual)

June 14, 2017

Study Record Updates

Last Update Posted (Estimated)

September 8, 2025

Last Update Submitted That Met QC Criteria

September 4, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GIMI-IRB-17004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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