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| Name | Class |
|---|---|
| Chinese PLA General Hospital | OTHER |
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The purpose of this study is to evaluate the safety and efficiency of allogeneic cluster of differentiation 33 (CD33)-directed chimeric antigen receptor modified T cells (CART-33) infusions in patients with relapsed / refractory acute myeloid leukemia (AML).
The relapsed and/or refractory AML patients will receive infusions of allogeneic CART-33 within 1 week after chemotherapy. The re-induction chemotherapy regimen was primarily idarubicin and cytarabine, and no graft-versus-host disease (GVHD) prevention was conducted pre- and post- therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| allogeneic CART-33 | Experimental | infusions of allogeneic CD33-directed chimeric antigen receptor-modified T cells (CART-33) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| allogeneic CART-33 | Biological | allogeneic CD33-directed chimeric antigen receptor-modified T cells (CART-33) |
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| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of study related adverse events | defined as >= Grade 3 signs/symptoms, laboratory toxicities, and clinical events) that are possibly, likely, or definitely related to study treatment Adverse events assessed according to NCI-CTCAE v4.0 criteria | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate of allogeneic CART-33 | A response is defined as: (1) a morphologic complete remission (CR) or (2) a complete remission with incomplete recovery of counts (CRi) (based on NCCN guidelines (National Comprehensive Cancer Network (NCCN), 2015) or (3) a negative minimal residual disease assessed by flow cytometry or qPCR | up to 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Huisheng Ai, MD | Contact | 861066947135 |
| Name | Affiliation | Role |
|---|---|---|
| Huisheng Ai, MD | Affiliated Hospital of Academy of Military Medical Sciences | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Affiliated Hospital of Academy of Military Medical Sciences | Recruiting | Beijing | Beijing Municipality | 100071 | China |
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| Disease-free survival | up to 24 weeks |
| Overall survival | up to 24 weeks |
| Chinese PLA General Hospital | Recruiting | Beijing | Beijing Municipality | 100853 | China |
|