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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.

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.

Condition or disease Intervention/treatment Phase
Lymphoma, B-Cell Biological: ET190L1 ARTEMIS™ T cells Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 21 participants
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : September 9, 2017
Estimated Primary Completion Date : June 21, 2021
Estimated Study Completion Date : June 21, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: i.v. arm
ET190L1 ARTEMIS™ T cells administered by intravenous (IV) infusion
Biological: ET190L1 ARTEMIS™ T cells
Autologous T cells transduced with lentivirus encoding an anti-CD19 (ET190L1) ARTEMIS™ expression construct




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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).

  6. 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).


Secondary Outcome Measures :
  1. 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).

  2. 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

  3. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03415399


Locations
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China
Peking University Cancer Hospital
Beijing, China, 100015
Sponsors and Collaborators
Eureka Therapeutics Inc.
Peking University
Investigators
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Principal Investigator: Jun Zhu, MD Peking University
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Responsible Party: Eureka Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT03415399    
Other Study ID Numbers: ETCH17CD19AR103
First Posted: January 30, 2018    Key Record Dates
Last Update Posted: July 22, 2020
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eureka Therapeutics Inc.:
relapsed/refractory CD19+ Lymphomas, B-Cell
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin