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

PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

October 11, 2019

Primary Completion Date

June 12, 2024

Study Completion Date

March 31, 2029

Conditions
Lymphomas Non-Hodgkin's B-CellDiffuse 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

Trial Locations (1)

6021

Wellington Hospital, Te Whatu Ora Health New Zealand Capital Coast & Hutt Valley, Wellington

All Listed Sponsors
collaborator

Wellington Zhaotai Therapies Limited

INDUSTRY

lead

Malaghan Institute of Medical Research

OTHER