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This is an open single-arm clinical study aimed at evaluating the efficacy and safety of universal γδT cell injection in the treatment of patients with relapsed AML after transplantation
Main purpose: To evaluate the safety and effectiveness of universal CAR-γδT cell injection in the treatment of patients with relapsed AML after transplantation
Secondary purpose: to investigate the in vivo dynamics characteristics of universal CAR-γδT cells after infusion and explore reasonable therapeutic doses through climbing tests in different dose groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CAR--γδT | Experimental | Patients will be treated with CAR--γδT cells |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CAR-γδT | Biological | Biological: CAR-γδT; Drug: Cyclophosphamide,Fludarabine; Procedure: Leukapheresis; |
|
| 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 |
| Efficacy: Remission Rate | Remission Rate including complete remission(CR)、CR with incomplete blood count recovery(CRi)、No remission(NR) | 3 months post CAR-T cells infusion |
| Measure | Description | Time Frame |
|---|---|---|
| duration of response (DOR) | duration of response (DOR) | 24 months post CAR-T cells infusion |
| Efficacy: progression-free survival (PFS) | progression-free survival (PFS) time |
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Inclusion Criteria:
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; 7. 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; 8. Subject or guardian understands and signs the informed consent;
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Peihua MD Lu, PhD | Contact | 008618611636172 | peihua_lu@126.com | |
| Jianqiang MD Li, PhD | Contact | 008615511369555 | limmune@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Peihua MD Lu, PhD | Hebei Yanda Ludaopei Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hebei yanda Ludaopei Hospital | Recruiting | Yanda | Hebei | China |
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| 24 months post CAR-T cells infusion |
| CAR-T proliferation | the copy number of CAR- γδT cells in the genomes of PBMC by qPCR method | 3 months post CAR-T cells infusion |
| Cytokine release | Cytokine( IL-6,IL-10,IFN-γ,TNF-α ) concentration (pg/mL) by flow cytometry method | First 1 month post CAR-T cells infusion |