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To evaluate the safety of general-purpose CAR-γδT cells in patients with refractory post-transplant relapsed AML.
To evaluate the efficacy and in vivo dynamics of general-purpose CAR-γδT cells in the treatment of refractory relapsed AML patients, and to explore the appropriate therapeutic dose and delivery mode.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CAR--γδT | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CAR--γδT cells | Biological | Biological: CAR-γδT; Drug: |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety: Incidence and severity of adverse events | To evaluate the possible adverse events occurred within first one month after CAR-γδT infusion, including the incidence and severity of symptoms such as cytokine release syndrome and neurotoxicity | First 1 month post CAR-T cells infusion |
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Inclusion Criteria:
The clinical diagnosis was difficult to treat recurrent acute myeloid leukemiaï¼›
Flow cytometry (FCM) or immunohistochemistry of tumor~ cells confirmed positive expression of CD123ï¼›
18 years old ≤ age ≤70 years old;
The expected survival from the date of informed consent is more than 3 months;
ECOG≤2;
The functions of vital organs shall meet the following conditions:
1) EF>50%, and no obvious ECG abnormality; 2) SpO2 90% or more; 3) Cr 2.5 ULN or less; 4) ALT And AST≤5ULN, TBil≤3ULN;
Subjects who plan to become pregnant must agree before study enrollment and after study duration of 6 months Use contraception; Inform the investigator immediately if the subject is pregnant or suspected to be pregnant;
Subject or guardian understands and signs the informed consent.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liang Huang, PhD | Contact | 027-83665555 | ||
| Jianqiang Li, PhD | Contact | 008615511369555 | limmune@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Liang Huang, PhD | Tongji Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tongji Hospital | Recruiting | Wuhan | Hubei | China |
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