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

Eureka Therapeutics

Status and phase

Completed

Phase 1

Conditions

Lymphoma, B-Cell

Treatments

Biological: ET190L1 ARTEMIS™ T cells

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03415399

ETCH17CD19AR103

Details and patient eligibility

About

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.

Full 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.

Enrollment

4 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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