Intervention of Bladder Cancer by CAR-T

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

Status

Terminated

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03185468

Enrollment

Registered

2017-06-14

Start date

2025-08-01

Completion date

2026-07-31

Last updated

2026-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bladder Cancer, Urothelial Carcinoma Bladder

Keywords

CAR T, Bladder

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.

Interventions

GENETIC4SCAR-PSMA

PSMA-specific 4th Generation CART

GENETIC4SCAR-FRa

FRa-specific 4th Generation CART

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Overall Survival rate after receiving 4SCART infusion	1 year	to determine the efficacy of 4SCAR T cells
Using CTCAE 4 standard to evaluate the level of adverse events after receiving 4SCART infusion	3 months	to evaluate the level of adverse events with CTCAE 4

Secondary

Measure	Time frame	Description
The expansion and persistence of 4SCAR T cells	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
Immune responses after infusions	3 months	assessment of cytokine profile

Countries

China

Contacts

PRINCIPAL_INVESTIGATORLung-Ji Chang, PhD

Shenzhen Geno-Immune Medical Institute

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 25, 2026