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| Name | Class |
|---|---|
| Asoarx Therapeutics Co., Ltd., Shanghai Branch | UNKNOWN |
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This is a single-arm, open-label, dose-escalation clinical trial. The entire trial is preliminarily expected to enroll 5 to 9 subjects.
The initial plan is to explore three dose groups: 2.5×10⁷, 7.5×10⁷, and 2.5×10⁸ cells/kg, with 3 subjects in each group. During the trial, based on a comprehensive assessment by the Safety Review Committee (SRC), the dose, dosing frequency, or dosing interval may be adjusted or increased.
In the dose-escalation phase, for the same dose group, one subject will be enrolled first. After obtaining at least 4 weeks of safety data, and upon the investigator's assessment confirming that the safety and tolerability risks are controllable, the second and third subjects can be enrolled. If the efficacy and safety data of the first subject in a dose group, based on the investigator's comprehensive judgment, indicate a significantly insufficient pharmacological effect, the study may proceed directly to the next dose group.
Before proceeding to each subsequent dose group, the SRC must evaluate the safety and pharmacodynamic data from the previous dose group for at least 4 weeks. Enrollment for the next group can only begin after the SRC confirms that the safety and tolerability risks are controllable and that the next dose level remains appropriate. The dose escalation will be determined based on safety data, combined with pharmacodynamic and efficacy data.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AXA-NK02 | Experimental | Up to three sequential AXA-NK02 dose levels (2.5e7、7.5e7、2.5e8 CAR-NK cells/kg)are planned. Each subject will accept four doses of AXA-NK02 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AXA-NK02 | Biological | Off-the-shelf NK cell products derived from human embryonic stem cells (hESCs) |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of Adverse Events | through study completion, an average of 2 year |
| Measure | Description | Time Frame |
|---|---|---|
| SLE remission ratio | through study completion, an average of 2 year | |
| Ratio of complete/partial remissions in kidney | through study completion, an average of 2 year |
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Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lei Yin | Contact | 13641673203 | yinlei@scmc.com.cn |
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IPD will be shared with other researchers when AXA-NK02 is fully approved.
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