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| Name | Class |
|---|---|
| Nanjing Calmhome Cell and Gene Engineering Institute Co., Ltd. | INDUSTRY |
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Evaluate the safety and efficacy of mesothelin-targeting UCAR-T cells in the treatment of mesothelin-positive advanced pancreatic cancer
3 planned dose cohorts will be evaluated during dose escalation phase. The dose expansion will be initiated after SRC (safety review committee) review the avaliable safety, PK and preliminary efficacy data.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CHT102 infusion | Experimental | CHT102 will be dosing by arterial infusion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CHT102 | Drug | CHT 102 : MSLN UCAR-T. |
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| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability | Treatment-related adverse events were recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0) | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | The total response rate after 90 days of treatment with study drug. | At 4 weeks, and overall |
| Disease control rate (DCR) | The disease control rate after 90 days of treatment with study drug. |
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Inclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jihui Hao, Ph.D | Contact | +86-02223340123 | haojihui@tjmuch.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin Medical University Cancer Institute & Hospital | Recruiting | Tianjin | China |
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| At 4 weeks, and overall |
| Progress-free survival(PFS) | PFS will be assessed from the first CHT102 infusion to death from any cause or the first assessment of progression (Assessed based on RECIST criteria) | 2 years |
| Overall survival (OS ) | OS will be assessed from the first CHT102 infusion to death from any cause (Assessed based on RECIST criteria) | 3 years |
| pharmacokinetics (PK) | Concentration levels of MSLN+ CAR-T cells | 6 months |
| PD | Concentration levels of MSLN U CAR-T-related serum cytokines, such as IL-2, IL-4, IL-6, IL-10, IFN-γ, TNF-α, etal | 6 months |