Ignite Creation Date:
2025-12-25 @ 1:12 AM
Ignite Modification Date:
2026-01-03 @ 9:31 PM
Study NCT ID:
NCT03379493
Status:
TERMINATED
Last Update Posted:
2019-02-04
First Post:
2017-12-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of ET190L1 ARTEMIS™ T Cells in Relapsed and Refractory CD19+ Non-Hodgkin's Lymphoma
Sponsor:
Eureka Therapeutics Inc.
Organization:
Study Overview
Official Title:
Open-label Phase I Study of ET190L1 ARTEMIS™ T Cells in Relapsed and Refractory CD19+ Non-Hodgkin's Lymphoma
Status:
TERMINATED
Status Verified Date:
2019-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor's Decision
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: