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| Name | Class |
|---|---|
| Nanjing Calmhome Cell and Gene Engineering Institute Co., Ltd. | INDUSTRY |
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Objectives of Study:In this study investigators plan to evaluate the safety and efficacy of MSLN-targeting Universal Chimeric Antigen Receptor T-Cell Immunotherapy(U CAR-T) in the treatment of MSLN-positive advanced solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CHT102 allogeneic CAR T cells | Experimental | In the dose escalation phase of this study, one alternative dose and 4 dose groups (calculated by the number of CAR-positive T cells) were planned, each treatment lasted 28 days, and UCAR-T cells were transfused three times, respectively on D1, D5, and D9. The single dose within the group was fixed, and the dose between the groups was escalating dose. Each infusion dose was 2.5×106/kg (optional), 5×106/kg, 1×107/kg, 2×107/kg, and 3×107/kg, with a dose error of 20% allowed. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CHT102 allogeneic CAR T cells | Biological | CHT102 allogeneic CAR T cells |
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| Measure | Description | Time Frame |
|---|---|---|
| Dose Limiting Toxicities (DLTs) occurence | Adverse events assessed according to NCI-CTCAE v5.0 criteria | Baseline up to 28 days after U CAR-T infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate | The total response rate after 90 days of treatment with study drug. | At 4 weeks, and overall |
| Progression-free survival | Progression-free survival rate following drug therapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin Medical University Cancer Institute & Hospital | Recruiting | Tianjin | Tianjin Municipality | China |
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| Assessed up to 6 months |