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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 4SCAR-PSMA | Genetic | PSMA-specific 4th Generation CART |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The expansion and persistence of 4SCAR T cells | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lung-Ji Chang, PhD | Contact | 86-13671121909 | c@szgimi.org |
| Name | Affiliation | Role |
|---|---|---|
| Lung-Ji Chang, PhD | Shenzhen Geno-Immune Medical Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shenzhen Geno-immune Medical Institute | Recruiting | Shenzhen | Guangdong | 518000 | China |
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| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| 4SCAR-FRa |
| Genetic |
FRa-specific 4th Generation CART |
|
assessment of cytokine profile |
| 3 months |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |