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Completed

NCT Number: NCT03415399

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

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.

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Key information

Conditions

Lymphoma, B-Cell Disease Attributes Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Peking University Cancer Hospital

Beijing, 100015, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ET190L1 ARTEMIS™ T cells

Biological

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Eureka Therapeutics Inc.

Industry

Collaborators

  • Peking University

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Jan 30, 2018
Registry last updated
Mar 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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