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

NCT ID: NCT03415399

Last Updated: 2021-03-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-09
• Study Completion Date: 2020-12-31

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.

Conditions

Lymphoma, B-Cell

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

i.v. arm

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

Group Type: EXPERIMENTAL

ET190L1 ARTEMIS™ T cells

Intervention Type: BIOLOGICAL

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

Interventions

ET190L1 ARTEMIS™ T cells

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

Intervention Type: BIOLOGICAL

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University

OTHER

Sponsor Role: collaborator

Eureka Therapeutics Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jun Zhu, MD

Role: PRINCIPAL_INVESTIGATOR

Peking University

Locations

Peking University Cancer Hospital

Beijing, , China

Countries

China

Other Identifiers

ETCH17CD19AR103

Identifier Type: -

Identifier Source: org_study_id