Trial | NCT03415399  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    4
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.
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 Started
Sep 09
2017
Primary Completion
Dec 31
2020
Study Completion
Dec 31
2020
Last Update
Mar 16
2021

Biological ET190L1 ARTEMIS™ T cells

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

i.v. arm Experimental

ET190L1 ARTEMIS™ T cells administered by intravenous (IV) infusion

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
No Results Posted