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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 CD70-targeting UCAR-T cells in the treatment of CD70-positive advanced solid tumors.
4 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 |
|---|---|---|---|
| CHT101 infusion | Experimental | CHT 101 will be dosing by IV. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CHT101 | Biological | CHT101: CD 70 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 proportion of subjects who achieved CR, PR after CAR-T infusion accounted for all treated subjects (Assessed based on RECIST criteria),the minimum value is 0%,maximum value is 100%, and higher scores mean a better outcome. | 28 days |
| Disease control rate (DCR) |
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Inclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xin Yao, Ph.D | Contact | +86-02223340123 | yaoxin1969@yahoo.com.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin Medical University Cancer Institute and Hospital | Recruiting | Tianjin | China |
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| ID | Term |
|---|---|
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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The proportion of subjects who achieved CR, PR, SD after CAR-T infusion accounted for all treated subjects (Assessed based on RECIST criteria),the minimum value is 0%,maximum value is 100%, and higher scores mean a better outcome. |
| 28 days |
| Progress-free survival(PFS) | PFS will be assessed from the first CD70 UCAR-T cell 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 CD70 UCAR-T cell infusion to death from any cause (Assessed based on RECIST criteria) | 3 years |
| pharmacokinetics (PK) | Concentration levels of CD70+ CAR-T cells | 6 months |
| Pharmacodynamics (PD) | Concentration levels of CD70 U CAR-T-related serum cytokines, such as IL-2, IL-4, IL-6, IL-10, IFN-γ, TNF-α | 6 months |