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Clinical Study of ET190L1 ARTEMIS™ in Relapsed, Refractory B Cell Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03415399
Recruitment Status : Active, not recruiting
First Posted : January 30, 2018
Last Update Posted : July 22, 2020
Sponsor:
Collaborator:
Peking University
Information provided by (Responsible Party):
Eureka Therapeutics Inc.

Tracking Information
First Submitted Date  ICMJE January 23, 2018
First Posted Date  ICMJE January 30, 2018
Last Update Posted Date July 22, 2020
Actual Study Start Date  ICMJE September 9, 2017
Estimated Primary Completion Date June 21, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 23, 2018)
  • Maximum Tolerated Dose [ Time Frame: 28 days up to 24 months ]
    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.
  • Toxicity profile of ET190L1 ARTEMIS™ T-cell treatment [ Time Frame: 28 days up to 24 months ]
    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.
  • Tmax of serum cytokine levels [ Time Frame: 24 weeks ]
    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.
  • Time to baseline for serum cytokine levels [ Time Frame: 24 weeks ]
    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.
  • AUC of serum cytokine levels [ Time Frame: 24 weeks ]
    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).
  • Duration of in vivo engraftment of ET190L1 ARTEMIS™ T cells [ Time Frame: 24 months ]
    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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 23, 2018)
  • Rate of disease response [ Time Frame: 28 days to 24 months ]
    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).
  • Anti-tumor responses [ Time Frame: 4 months, 1 year, 2 years ]
    Progression free survival (PFS) and Median survival (MS) at 4 months, 1 year, 2 years
  • B cell depletion [ Time Frame: 2 years ]
    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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Study of ET190L1 ARTEMIS™ in Relapsed, Refractory B Cell Lymphoma
Official Title  ICMJE Phase 1, Open-label, Single-arm, Dose-escalation Clinical Study Evaluating the Safety and Efficacy of ET190L1 ARTEMIS™ (Anti-CD19-ARTEMIS™) in Relapsed, Refractory B Cell Lymphoma
Brief 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.
Detailed 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Lymphoma, B-Cell
Intervention  ICMJE Biological: ET190L1 ARTEMIS™ T cells
Autologous T cells transduced with lentivirus encoding an anti-CD19 (ET190L1) ARTEMIS™ expression construct
Study Arms  ICMJE Experimental: i.v. arm
ET190L1 ARTEMIS™ T cells administered by intravenous (IV) infusion
Intervention: Biological: ET190L1 ARTEMIS™ T cells
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: January 23, 2018)
21
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 21, 2021
Estimated Primary Completion Date June 21, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03415399
Other Study ID Numbers  ICMJE ETCH17CD19AR103
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Eureka Therapeutics Inc.
Study Sponsor  ICMJE Eureka Therapeutics Inc.
Collaborators  ICMJE Peking University
Investigators  ICMJE
Principal Investigator: Jun Zhu, MD Peking University
PRS Account Eureka Therapeutics Inc.
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP