NCT03379493

Study of ET190L1 ARTEMIS™ T Cells in Relapsed and Refractory CD19+ Non-Hodgkin's Lymphoma

Open-label Phase I Study of ET190L1 ARTEMIS™ T Cells in Relapsed and Refractory CD19+ Non-Hodgkin's Lymphoma

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Eureka Therapeutics Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a non-randomized, single arm, open-label, single institution, phase I study to determine the maximum tolerated dose (MTD) of ET190L1 ARTEMIS™ T cells in patients ≥ 18 years of age with relapsed or refractory CD19+ Non-Hodgkin's lymphoma.

Detailed description

The trial will follow a traditional dose-escalation model to establish the MTD and recommended phase 2 dose (RP2D) of infused ET190L1 ARTEMIS™ T cells following lympho-depleting chemotherapy. Two sequential cohorts of patients will be recruited to fulfill this study, those in the dose escalation cohort (for determination of MTD and RP2D) and those in the expansion cohort (treated on the RP2D). The study will have concurrent phases of screening, pre-treatment, treatment, primary follow-up, safety, and survival follow-up. The total duration of the study involvement for the patient is 15 years. Efficacy will be assessed until progression and safety will be assessed throughout the full duration of the study. Twelve to 24 patients will be treated to determine the MTD. Following determination of the MTD, an expansion cohort consisting of 6 patients per disease subtype (n= 30) will be recruited.

Conditions

• Lymphomas Non-Hodgkin's B-Cell

Interventions

Type	Name	Description
BIOLOGICAL	ET190L1 ARTEMIS™ T cells	Autologous T cells transduced with lentivirus encoding an anti-CD19 (ET190L1) ARTEMIS™ expression construct, administered by intravenous (IV) infusion

Timeline

• Start date: 2018-04-04
• Primary completion: 2018-12-23
• Completion: 2019-01-30
• First posted: 2017-12-20
• Last updated: 2019-02-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study