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The purpose of this clinical investigation is to evaluate the safety and effects of NKG2D-CAR-NK92 infusions in the treatment of relapsed/refractory solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NKG2D-CAR-NK92 cells immunotherapy | Experimental | Preparation of NKG2D-CAR-NK92 cells suspended in saline solution. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NKG2D-CAR-NK92 cells | Biological | NKG2D-CAR-NK92 cells will be administered intravenously over 1h. The starting dose of NKG2D-CAR-NK92 cells will be 0.5×10^6-2×10^6/kg, twice a week. The first evaluation of the efficacy after 3 weeks of treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events evaluated with CTCAE, version 4.0 | Safety evaluation | 3 months |
| Objective Response Rate | Solid tumors to NKG2D-CAR-NK92 cells infusions | up to one year |
| Measure | Description | Time Frame |
|---|---|---|
| Disease Control Rate | up to one year | |
| Progression-free Survival | up to one year | |
| Overall Survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wuling Zhu | Contact | 008603733029089 | wulingzhu@xxmu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The first Affiliated Hospital of Xinxiang Medical University | Recruiting | Xinxiang | Henan | 453000 | 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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| up to one year |
| Quality of Life Score | We use the 26 items self-rating questionnaire WHOQOL-BREF to assess the Quality of Life Score, which measures physical health, psychological health, social relationships, and environment during the last two weeks. | up to one year |