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The purpose of this clinical trial is to assess the feasibility, safety and efficacy of multi-CAR T cell therapy targeting different AML surface antigens in patients with relapsed or refractory acute myeloid leukemia (AML). Another goal of the study is to learn more about the function of the multi-CAR T cells and their persistency in the patients.
Acute myeloid leukemia (AML) is a malignant disease characterized by the rapid growth of myeloblasts that build up in the bone marrow and interfere with the production of normal blood cells.
In this study, the patients' own T cells will be genetically modified with lentiviral vectors expressing chimeric antigen receptors. The multi-CAR T cells recognize specific molecules such as CD33, CD38, CD123, CD56, MucI, and CLL1, which are often found expressed on the surface of AML cells. The engineered CAR T cells will be infused into patients.
The purpose of this clinical study is to assess the feasibility, safety and efficacy of the multi-CAR T cell therapy against AML. Another goal of the study is to learn more about the function of the multi-CAR T cells and their persistency in the patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single arm | Experimental | CAR T cells to treat AML |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Muc1/CLL1/CD33/CD38/CD56/CD123-specific gene-engineered T cells | Biological | Infusion of Muc1/CLL1/CD33/CD38/CD56/CD123-specific gene-engineered T cells |
|
| Measure | Description | Time Frame |
|---|---|---|
| percentage of patients with treatment related adverse effect | percentage of participants with treatment-related adverse events, as assessed by physical exam, vital signs, standard clinical labs and so on. | a year |
| Measure | Description | Time Frame |
|---|---|---|
| Anti tumor activity of fourth generation CAR-T cells in patients with relapsed or refractory AML | scale of CAR copies and leukemic cell burden (for efficacy) | a year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lung-Ji Chang | Contact | +86 0755-86573763 | c@szgimi.org |
| Name | Affiliation | Role |
|---|---|---|
| Lung-Ji Chang | Shenzhen Geno-Immune Medical Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shenzhen Geno-immune Medical Institute | Recruiting | Shenzhen | Guangdong | 518000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37031462 | Derived | Pei K, Xu H, Wang P, Gan W, Hu Z, Su X, Zhang H, He Y. Anti-CLL1-based CAR T-cells with 4-1-BB or CD28/CD27 stimulatory domains in treating childhood refractory/relapsed acute myeloid leukemia. Cancer Med. 2023 Apr;12(8):9655-9661. doi: 10.1002/cam4.5916. Epub 2023 Apr 9. |
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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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| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |