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| Name | Class |
|---|---|
| Eureka Therapeutics Inc. | INDUSTRY |
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This study is to determine the safety, including potential dose limiting toxicities, and efficiency of ET019002-T cells and the duration of in vivo survival of ET019002-T cells in patients with relapsed/refractory B-Cell Malignancies.
ET019002-T cell therapy is a novel chimeric T-cell therapy platform that in preclinical studies, functionally matches the efficacy of CAR-T cells, but dramatically reduces the release of cytokines upon killing of target-positive tumors.The arm of the study is experimental i.v. arm:ET019002-T cells administered by intravenous (IV) infusion.The intervention is ET019002-T cells(Autologous T cells transduced with lentivirus encoding an anti-CD19 (ET019002)-expression construct).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The low dose group | Experimental |
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| The middle dose group | Experimental |
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| The high dose group | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low dose ET019002- T Cells | Biological | ET019002- T Cells are autologous T cells transduced expressing a novel anti-CD19 (ET019002) chimeric antigen receptor,and are administered by intravenous infusion with the dose of 0.75×10*6/kg. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Tolerated Dose | A dose limiting toxicity is defined as any toxicity that is considered to be primarily related to the ET019002T-cells,which is irreversible or life threatening or CTCAE Grade 3-5. | Up to 12 weeks. |
| Tmax of serum cytokine levels | Cytokins as measured by CBA-Bioplex Multiplex Immunoassays will be presented as time to peak level. | Up to 12 weeks. |
| Time to baseline for serum cytokine levels | Inceases or decreases in the amout of cytokine produced compared to baseline at time points measured up to 24 weeks since dosing. | Up to 12 weeks. |
| Toxicity profile of ET019002T-cell treatment | Frequency of treatment-related adverse events that occurred at any time from the first day of infusion that are "possibly", "likely", or "definitely" related to the study, including infusion related toxicity and ET019002 T cell related toxicity. Include but not limited to: Fever, chills, nausea, vomiting, jaundice and other gastrointestinal symptoms; Fatigue, hypotension, respiratory distress; Tumor lysis syndrome; Cytokine release syndrome; Neutropenia, thrombocytopenia; Liver and kidney dysfunction. Assessed at all visits. | Up to 2 years. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of disease response | Rate of disease response assessed by lugano cliassification.Response rates will be estimated as CR,PR,SD,PD. | Up to 12 weeks. |
| Progression free survival(PFS) | Progression free survival(PFS) denotes the chances of staying free of disease progression for patients after treatment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| He Peng cheng, Doctor | Contact | 0086-18991232609 | He Pengcheng | hepc@163.com |
| Name | Affiliation | Role |
|---|---|---|
| He Peng cheng, Doctor | First Affiliated Hospital of Xian JiaotongUniversity | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35776199 | Derived | He P, Liu H, Zimdahl B, Wang J, Luo M, Chang Q, Tian F, Ni F, Yu D, Liu H, Chen L, Wang H, Zhang M, Grupp SA, Liu C. A novel antibody-TCR (AbTCR) T-cell therapy is safe and effective against CD19-positive relapsed/refractory B-cell lymphoma. J Cancer Res Clin Oncol. 2023 Jul;149(7):2757-2769. doi: 10.1007/s00432-022-04132-9. Epub 2022 Jul 1. |
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| Middle dose ET019002- T Cells | Biological | ET019002- T Cells are autologous T cells transduced expressing a novel anti-CD19 (ET019002) chimeric antigen receptor,and are administered by intravenous infusion with the dose of 1.5×10*6/kg. |
|
| High dose ET019002- T Cells | Biological | ET019002- T Cells are autologous T cells transduced expressing a novel anti-CD19 (ET019002) chimeric antigen receptor,and are administered by intravenous infusion with the dose of 3.0×10*6/kg. |
|
| Up to 2 years. |
| Time to baseline for B cell level | B cell level as measured by Bio-Plex Multiplex Immunoassays will be presented. | Up to 2 years. |