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

NCT04049513 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-08-21

No results posted yet for this study

Summary

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.

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)

Interventions

BIOLOGICAL

WZTL002-1 (1928T2z CAR-T cells)

WZTL-002 comprises autologous third-generation anti-CD19 chimeric antigen receptor T-cells (termed 1928T2z). The chimeric antigen receptor in WZTL-002 incorporates the FMC63 anti-CD19 soluble chain variable fragment extracellularly, and portions of both CD28 and the Toll/interleukin-1 receptor (TIR) domain of Toll Like Receptor 2 (TLR2) as intracellular co-stimulatory domains, alongside CD3ζ. WZTL-002 (autologous 1928T2z CAR T-cells) will be administered on D0 as a single IV infusion, following lymphodepleting chemotherapy.

DRUG

Cyclophosphamide and Fludarabine lymphodepleting chemotherapy

Cyclophosphamide 500 mg/m\^2 IV on days -5 to -3, inclusive. Fludarabine 30 mg/m\^2 IV on days -5 to -3, inclusive

Sponsors & Collaborators

  • Wellington Zhaotai Therapies Limited

    collaborator INDUSTRY

  • Malaghan Institute of Medical Research

    lead OTHER

Principal Investigators

  • Robert Weinkove, MBBS, PhD · Te Whatu Ora Health New Zealand Capital Coast & Hutt Valley

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
16 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-11
Primary Completion
2024-06-12
Completion
2029-03-31

Countries

  • New Zealand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04049513 on ClinicalTrials.gov