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This is a single center, open-label phase 1/2 study to evaluate the safety and efficacy of targeted CD38 chimeric antigen receptor engineered T cell immunotherapy (CART) in the treatment of CD38 positive relapsed or refractory acute myeloid leukemia.
The patients will receive infusion of CAR T-cells targeting CD38 to confirm the safety and efficacy of CD38 CAR T-Cells in relapsed or refractory acute myeloid leukemia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CD38 positive relapsed or refractory acute myeloid leukemia | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CART-38 | Biological | Split intravenous infusion of CART-38 cells [dose escalating infusion of (5-20)x10^6 CART-38 cells/kg]. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Adverse Events | Adverse events are evaluated with CTCAE V5.0 | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate (ORR) | ORR includes CR, CRi, MLFS and PR. Complete remission (CR)：Bone marrow blasts <5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count >1.0x 10^9/L; platelet count >100x10^9/L. CR with incomplete hematologic recovery (CRi)：All CR criteria except for residual neutropenia (<1.0x10^9/L) or thrombocytopenia (<100x10^9/L). Morphologic leukemia-free state (MLFS): Bone marrow blasts <5%; absence of blasts with Auer rods; absence of extramedullary disease; no hematologic recovery required. Partial remission (PR): All hematologic criteria of CR; decrease of bone marrow blast percentage to 5% to 25%; and decrease of pretreatment bone marrow blast percentage by at least 50%. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaowen Tang, Ph.D | Contact | (0086)51267781856 | xwtang1020@163.com | |
| Lei Yu, Ph.D | Contact | (0086)13818629089 | ylyh188@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiaowen Tang, Ph.D | The First Affiliated Hospital of Soochow University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Soochow University | Recruiting | Suzhou | Jiangsu | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36524116 | Derived | Cui Q, Liang P, Dai H, Cui W, Cai M, Ding Z, Ma Q, Yin J, Li Z, Liu S, Kang L, Yao L, Cen J, Shen H, Zhu M, Yu L, Wu D, Tang X. Case report: CD38-directed CAR-T cell therapy: A novel immunotherapy targeting CD38- positive blasts overcomes TKI and chemotherapy resistance of myeloid chronic myeloid leukemia in blastic phase. Front Immunol. 2022 Nov 29;13:1012981. doi: 10.3389/fimmu.2022.1012981. eCollection 2022. | |
| 34034795 |
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| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| 2 years |
| Event-free survival (EFS) | time from enrollment to the date of primary refractory disease, or relapse from CR or CRi, or death from any cause. | 2 years |
| Cumulative incidence of relapse(CIR) | time from the date of achievement of a remission until the date of relapse. | 2 years |
| Derived |
| Cui Q, Qian C, Xu N, Kang L, Dai H, Cui W, Song B, Yin J, Li Z, Zhu X, Qu C, Liu T, Shen W, Zhu M, Yu L, Wu D, Tang X. CD38-directed CAR-T cell therapy: a novel immunotherapy strategy for relapsed acute myeloid leukemia after allogeneic hematopoietic stem cell transplantation. J Hematol Oncol. 2021 May 25;14(1):82. doi: 10.1186/s13045-021-01092-4. |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |