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NCT04049513 · ClinicalTrials.gov record · last posted 2024-08-21

ENABLE-1 (Engaging Toll-like Receptor Signalling for B-cell Lymphoma Chimeric Antigen Receptor Therapy)

Study acronym: ENABLE-1
StatusActive, Not Recruiting
PhasePhase 1
Started2019-10-11
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from the ClinicalTrials.gov record
This Phase 1, single centre, open label dose escalation study aims to identify a safe dose of third-generation anti-CD19 CAR T-cells (WZTL-002) in the treatment of patients with relapsed or refractory (r/r) B-cell Non Hodgkin Lymphoma, for use in further efficacy trials. An expansion cohort will assess automated closed-system manufacture of WZTL-002 and outpatient management of participants.

Amendment record 6 amendments on the ClinicalTrials.gov record

This ClinicalTrials.gov record has been amended 6 times since 2019-08-06; most recent amendment 2024-08-19. DataLookout shows field-level changes from the day a trial enters its daily monitoring; earlier amendments are counted here from the ClinicalTrials.gov version history. See every version on ClinicalTrials.gov ↗

2024-06-11
Status change Recruiting→Active, Not Recruitingv5
2019-09-27
Status change Not Yet Recruiting→Recruitingv2
Trial Details
NCT Number NCT04049513
Lead Sponsor Malaghan Institute of Medical Research
Collaborators: Wellington Zhaotai Therapies Limited
Conditions Lymphomas Non-Hodgkin's B-Cell, Diffuse Large B-cell Lymphoma (DLBCL), Primary Mediastinal B-cell Lymphoma (PMBCL), Transformed Follicular Lymphoma (TFL), Follicular Lymphoma (FL), Mantle Cell Lymphoma (MCL)
Enrollment 30 participants
Start Date 2019-10-11
Primary Completion 2024-06-12 (estimated)
Study Completion 2029-03 (estimated)
Updated on ClinicalTrials.gov 2024-08-21