ET190L1-ARTEMIS™ T Cells in Relapsed, Refractory B Cell Leukemia and Lymphoma

Xi'an Jiaotong University

Status and phase: Unknown; Early Phase 1

Conditions: CD19+ Leukemia, B-Cell; CD19+ Lymphoma, B-Cell

Treatments: Biological: ET190L1-ARTEMIS™ T cells -iv low dose; Biological: ET190L1-ARTEMIS™ T cells - iv high dose; Biological: ET190L1-ARTEMIS™ T cells -iv middle dose

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03895944

XJTU1AF2017LSL-C001

Details and patient eligibility

About

Clinical study to evaluate safety and pharmacokinetics (primary objectives) and efficacy (secondary objective) of ET190L1-ARTEMIS™2 T-cells in patients with Cluster of Differentiation (CD) 19+ B cell Leukemia and Lymphoma

Full description

ARTEMIS™ is a novel chimeric T-cell therapy that in pre-clinical studies, functionally matches the efficacy of Chimeric Antigen Receptor (CAR) T cells, but dramatically reduces the release of cytokines upon killing of target positive tumors. The molecular target for ET190L1-ARTEMIS™ is Cluster of Differentiation 19 (CD19), which is expressed on B cell Lymphomas and B cell Leukemias. ET190L1-ARTEMIS™ is a second generation ARTEMIS™ receptor engineered with a human Fab antibody domain against CD19. This clinical study evaluates the safety and pharmacokinetics of ET190L1-ARTEMIS™ T-cells in patients with relapsed/refractory B-cell lymphoma and B-cell Leukemia.

Enrollment: 18 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with relapsed/refractory CD19+ B-cell lymphoma or Leukemia, with no effective therapy available per National Comprehensive Cancer Network (NCCN) guidelines
• Eastern Cooperative Oncology Group (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.
• Peripheral venous access is available and no issues with apheresis for lymphocyte isolation
• serum alanine aminotransferase(ALT)<200 Unit/L, ALT/Aspartate aminotransferase(AST)<3 normal range; serum creatinine (Cr)<2.5mg/dL
• 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
• Patients with dependence on corticosteroids
• Continuously used glucocorticoids or other immunosuppressive agents within 2 weeks
• T cell deficiency or T cells are difficult to be transduced
• Patients currently receiving other investigational treatments (biotherapy, chemotherapy, or radiotherapy)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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18 participants in 3 patient groups

iv low dose

Experimental group

Description:

Autologous ET190L1-ARTEMIS™ T cells administered by intravenous (IV) infusion with low dose (1x10^6) in Leukemia or Lymphoma patients

Treatment:

Biological: ET190L1-ARTEMIS™ T cells -iv low dose

iv middle dose

Experimental group

Description:

Autologous ET190L1-ARTEMIS™ T cells administered by intravenous (IV) infusion with middle dose (3x10^6) in Leukemia or Lymphoma patients

Treatment:

Biological: ET190L1-ARTEMIS™ T cells -iv middle dose

iv high dose

Experimental group

Description:

Autologous ET190L1-ARTEMIS™ T cells administered by intravenous (IV) infusion with high dose (10x10^6) in Leukemia or Lymphoma patients

Treatment:

Biological: ET190L1-ARTEMIS™ T cells - iv high dose