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| Name | Class |
|---|---|
| Eureka Therapeutics Inc. | INDUSTRY |
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Clinical study to evaluate safety and pharmacokinetics (primary objectives) and efficacy (secondary objective) of ET190L1-ARTEMIS™2 T-cells in patients with Cluster of Differentiation (CD) 19+ B cell Leukemia and Lymphoma
ARTEMIS™ is a novel chimeric T-cell therapy that in pre-clinical studies, functionally matches the efficacy of Chimeric Antigen Receptor (CAR) T cells, but dramatically reduces the release of cytokines upon killing of target positive tumors. The molecular target for ET190L1-ARTEMIS™ is Cluster of Differentiation 19 (CD19), which is expressed on B cell Lymphomas and B cell Leukemias. ET190L1-ARTEMIS™ is a second generation ARTEMIS™ receptor engineered with a human Fab antibody domain against CD19. This clinical study evaluates the safety and pharmacokinetics of ET190L1-ARTEMIS™ T-cells in patients with relapsed/refractory B-cell lymphoma and B-cell Leukemia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| iv low dose | Experimental | Autologous ET190L1-ARTEMIS™ T cells administered by intravenous (IV) infusion with low dose (1x10^6) in Leukemia or Lymphoma patients |
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| iv middle dose | Experimental | Autologous ET190L1-ARTEMIS™ T cells administered by intravenous (IV) infusion with middle dose (3x10^6) in Leukemia or Lymphoma patients |
|
| iv high dose | Experimental | Autologous ET190L1-ARTEMIS™ T cells administered by intravenous (IV) infusion with high dose (10x10^6) in Leukemia or Lymphoma patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ET190L1-ARTEMIS™ T cells -iv low dose | Biological | Autologous T cells transduced with lentivirus encoding an anti-CD19 (ET190L1) -ARTEMIS™ expression construct, 1x10^6 |
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| Measure | Description | Time Frame |
|---|---|---|
| Frequency of ARTEMIS T cell treatment-related adverse events | 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 ET190L1-ARTEMIS™ T T cells 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. | until 24 weeks |
| Number of ET190L1-ARTEMIS™ T cells in peripheral blood | Duration of in vivo engraftment of ET190L1-ARTEMIS™ T cells. Number of ET190L1-ARTEMIS™ T cells in peripheral blood will be presented as Time to peak, Time to baseline level and so on. | 24 months |
| % of ET190L1-ARTEMIS™ T cells in peripheral blood | Duration of in vivo engraftment of ET190L1-ARTEMIS™ T cells. % of ET190L1-ARTEMIS™ T cells in peripheral blood will be presented as Time to peak, Time to baseline level and so on. | 24 months |
| Maximum Tolerated Dose | Determine the safety, including potential dose limiting toxicities, of the ET190L1-ARTEMIS™ T cells. A dose limiting toxicity is defined as any toxicity that is considered to be primarily related to the ET190L1-ARTEMIS™ T cells, which is irreversible or life threatening or CTCAE Grade 3-5. Assessed at all visits. | 28 days up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Tmax of serum cytokine levels | Increase or decreases in the amount of cytokine produced compared to baseline at time points measured up to 24 weeks since dosing. Cytokines as measured by Bio-Plex Multiplex Immunoassays will be presented as time to peak level. | 24 weeks |
| Time to baseline for serum cytokine levels |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mei Zhang, PhD | Contact | 86-18991232153 | prozhangmei@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Mei Zhang, PhD | First Affiliated Hospital Xi'an Jiaotong University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Affiliated Hospital of Xi'an Jiaotong University | Recruiting | Xi'an | 710061 | China |
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| ET190L1-ARTEMIS™ T cells -iv middle dose | Biological | Autologous T cells transduced with lentivirus encoding an anti-CD19 (ET190L1) -ARTEMIS™ expression construct, 3x10^6 |
|
| ET190L1-ARTEMIS™ T cells - iv high dose | Biological | Autologous T cells transduced with lentivirus encoding an anti-CD19 (ET190L1) -ARTEMIS™ expression construct, 10x10^6 |
|
Increase or decreases in the amount of cytokine produced compared to baseline at time points measured up to 24 weeks since dosing. Cytokines as measured by Bio-Plex Multiplex Immunoassays will be presented as time to baseline. |
| 24 weeks |
| AUC of serum cytokine levels | Increase or decreases in the amount of cytokine produced compared to baseline at time points measured up to 24 weeks since dosing. Cytokines as measured by Bio-Plex Multiplex Immunoassays will be presented as area under curve (AUC). | 24 weeks |
| Rate of disease response | Rate of disease response assessed by Lugano classification (a lymphoma staging classification). Response rates will be estimated as the percent of patients with any of the following: complete remission (CR), partial response (PR). | 28 days to 24 months |
| Progression free survival (PFS) | Progression free survival (PFS) | 4 months, 1 year and 2 years |
| Median Survival（MS） | Median Survival（MS） | 4 months, 1 year and 2 years |
| Overall Survival（OS） | Overall Survival（OS） | 4 months, 1 year and 2 years |
| B cell depletion (Number) | Number of B cells in peripheral blood will be presented as time to baseline level and time to recover for up to 2 years. | 2 years |
| B cell depletion (%) | % of B cells in peripheral blood will be presented as time to baseline level and time to recover for up to 2 years. | 2 years |