Intervention of Bladder Cancer by CAR-T

NCT ID: NCT03185468

Last Updated: 2025-09-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-01

Study Completion Date

2029-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Bladder Cancer Urothelial Carcinoma Bladder

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

4SCAR-PSMA

Intervention Type GENETIC

PSMA-specific 4th Generation CART

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.

Group Type EXPERIMENTAL

4SCAR-FRa

Intervention Type GENETIC

FRa-specific 4th Generation CART

Interventions

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4SCAR-PSMA

PSMA-specific 4th Generation CART

Intervention Type GENETIC

4SCAR-FRa

FRa-specific 4th Generation CART

Intervention Type GENETIC

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shenzhen Geno-Immune Medical Institute

OTHER

Sponsor Role lead

Responsible Party

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Lung-Ji Chang

President

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lung-Ji Chang, PhD

Role: PRINCIPAL_INVESTIGATOR

Shenzhen Geno-Immune Medical Institute

Locations

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Shenzhen Second People Hospital

Shenzhen, Gongdong, China

Site Status RECRUITING

Shenzhen Geno-immune Medical Institute

Shenzhen, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Lung-Ji Chang, PhD

Role: CONTACT

86-13671121909

Aifa Tang, PhD

Role: CONTACT

Facility Contacts

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AiFa Tang, Ph. D

Role: primary

Lung-Ji Chang, PhD

Role: primary

86-13671121909

Other Identifiers

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GIMI-IRB-17004

Identifier Type: -

Identifier Source: org_study_id

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