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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03415399
Other study ID # ETCH17CD19AR103
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date September 9, 2017
Est. completion date December 31, 2020

Study information

Verified date March 2021
Source Eureka Therapeutics Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is to determine the safety, including potential dose limiting toxicities, of ET190L1 ARTEMIS™ T cells and the duration of in vivo survival of ET190L1 ARTEMIS™ T cells in patients with relasped/refractory B-cell lymphoma. For patients with detectable disease, the study will also measure anti-tumor responses after ET190L1 ARTEMIS™ cell infusions.


Description:

ET190L ARTEMIS™ 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.


Recruitment information / eligibility

Status Completed
Enrollment 4
Est. completion date December 31, 2020
Est. primary completion date December 31, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients with relapsed/refractory CD19+ B-cell lymphoma, with no effective therapy available per NCCN guidelines - No HCV, HIV infection, no active HBV - Liver and kidney function: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) does not exceed five times the upper limit of normal range. ALT <200U / L, bilirubin <2.0 mg/ dL - Renal function: creatinine <2.5mg / dL; Pre-treatment absolute creatinine clearance =50 mL / minute - CBC: Hemoglobin = 80g / L, Absolute Neutrophil Counts =1 × 10^9 / L, Platelets =50 × 10^9 / L - Echocardiography or multiple gated angiogram (MUGA) ejection fraction> 45% - ECOG performance status =2, expected survival time > 3 months per PIs opinion - Women of childbearing age should have a negative pregnancy test and agree to use effective contraception during treatment and 1 year after the last dose. - Had a recurrence after at least a first-line systemic treatment - Peripheral venous access is available and no issues with apheresis for lymphocyte isolation - Voluntarily signed informed consent form Exclusion Criteria: - Women in pregnancy and lactation - Unable to perform leukapheresis and iv infusion - With active infection - Major organ failure - Continuously used glucocorticoids or other immunosuppressive agents within 4 weeks - T cell deficiency or T cells are difficult to be transduced

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
ET190L1 ARTEMIS™ T cells
Autologous T cells transduced with lentivirus encoding an anti-CD19 (ET190L1) ARTEMIS™ expression construct

Locations

Country Name City State
China Peking University Cancer Hospital Beijing

Sponsors (2)

Lead Sponsor Collaborator
Eureka Therapeutics Inc. Peking University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 24 months
Primary Toxicity profile of ET190L1 ARTEMIS™ T-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 ET190L1 ARTEMIS™-cell 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. 28 days up to 24 months
Primary Tmax of serum cytokine levels Increases 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 Immuoassays will be presented as time to peak level. 24 weeks
Primary Time to baseline for serum cytokine levels Increases 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 Immuoassays will be presented as Time to baseline. 24 weeks
Primary AUC of serum cytokine levels Increases 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 Immuoassays will be presented as area under curve (AUC). 24 weeks
Primary Duration of in vivo engraftment of ET190L1 ARTEMIS™ T cells Number and % of ET190L1 ARTEMIS™ T cells in peripheral blood will be presented as Time to peak, Time to baseline level and the overall exposure will be presented as area under curve (AUC). 24 months
Secondary Rate of disease response Rate of disease response assessed by Lugano (Chason) classification. Response rates will be estimated as the percent of patients with complete remission (CR), partial response (PR), stable disease (SD), progression disease (PD), overall survival (OS). 28 days to 24 months
Secondary Anti-tumor responses Progression free survival (PFS) and Median survival (MS) at 4 months, 1 year, 2 years 4 months, 1 year, 2 years
Secondary B cell depletion Number and % 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
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