Intervention of Bladder Cancer by CAR-T

NCT03185468 | Recruiting Phase 1

• 1 other identifier: GIMI-IRB-17004
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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.

Conditions

Bladder Cancer; Urothelial Carcinoma Bladder

Keywords

CAR T; Bladder

Outcome Measures

Primary Outcomes (2)

• Overall Survival rate after receiving 4SCART infusion

  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

  to evaluate the level of adverse events with CTCAE 4

  3 months

Secondary Outcomes (2)

• The expansion and persistence of 4SCAR T cells

  1 year

• Immune responses after infusions

  3 months

Study Arms (2)

4SCAR-PSMA

EXPERIMENTAL

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

4SCAR-FRa

EXPERIMENTAL

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

Interventions

4SCAR-PSMA GENETIC

PSMA-specific 4th Generation CART

4SCAR-PSMA

4SCAR-FRa GENETIC

FRa-specific 4th Generation CART

4SCAR-FRa

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shenzhen Geno-Immune Medical Institute: lead

Study Sites (2)

Shenzhen Second People Hospital

Shenzhen, Gongdong, China

RECRUITING

Shenzhen Geno-immune Medical Institute

Shenzhen, Guangdong, 518000, China

RECRUITING

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Lung-Ji Chang, PhD

  Shenzhen Geno-Immune Medical Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lung-Ji Chang, PhD

CONTACT

86-13671121909; c@szgimi.org

Aifa Tang, PhD

CONTACT

tangaifa2004@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: President

Study Record Dates

• First Submitted: June 10, 2017
• First Posted: June 14, 2017
• Study Start: August 1, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: September 8, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)