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The goal of this clinical trial is to test TCR-like CAR-T in the Treatment of MSLN positive Ovarian Cancer. The main question it aims to answer are: the safety and efficacy of TCR-like CAR-T in the Treatment of MSLN positive Ovarian Cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental 1*10^6/kg | Experimental |
| |
| Experimental 1*10^7/kg | Experimental |
| |
| Experimental 3*10^6/kg | Experimental |
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| Experimental 2*10^7/kg | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TCR-like CAR-T | Biological | intravenous drip of TCR-like CAR-T with indicated doses |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum tolerated dose (MTD) of KT127 cells | The highest dose level (cells/kg) where ≤2/6 evaluable subjects experience protocol-defined dose-limiting toxicities (DLTs) within 14 days post-infusion, with dose escalation terminated based on pre-specified safety criteria. | up to second year |
| Adverse events (AEs) | The ASTCT 2019 standard will be used to grade cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS), and the CTCAE version 5.0 standard will be used to grade other adverse events. Unless otherwise specified in the protocol, all AEs that occur during the entire study period will be evaluated. | up to second year |
| Measure | Description | Time Frame |
|---|---|---|
| objective response rate(ORR) | The objective response rate evaluation will be based on the researcher's evaluation of imaging, and the efficacy evaluation will refer to the evaluation criteria for solid tumors (RECIST 1.1) The objective response rate evaluation will be based on the researcher's evaluation of imaging, and the efficacy evaluation will refer to the evaluation criteria for solid tumors(RECIST 1.1) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yang Shen, PhD | Zhongda Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongda hospital | Nanjing | Jiangsu | 210009 | China |
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dose climbing test
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| up to second year |
| progression-free survival(PFS) | Progressive free survival is the time from receiving investigational drug treatment to the onset of the first PD or death from any cause in the absence of documented PD | up to second year |
| Overall survival(OS) | The total survival period is the time between receiving investigational drug treatment and subject death due to various reasons | up to second year |