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

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.

Timeline

Start

2019-10-11

Primary completion

2024-06-12

Completion

2029-03

Publications

• Background George P, Dasyam N, Giunti G, Mester B, Bauer E, Andrews B, Perera T, Ostapowicz T, Frampton C, Li P, Ritchie D, Bollard CM, Hermans IF, Weinkove R. Third-generation anti-CD19 chimeric antigen receptor T-cells incorporating a TLR2 domain for relapsed or refractory B-cell lymphoma: a phase I clinical trial protocol (ENABLE). BMJ Open. 2020 Feb 9;10(2):e034629. doi: 10.1136/bmjopen-2019-034629.
• Weinkove R, George P, Ruka M, Haira TH, Giunti G. Chimeric antigen receptor T-cells in New Zealand: challenges and opportunities. N Z Med J. 2021 Sep 17;134(1542):96-108.
• Ernst M, Oeser A, Besiroglu B, Caro-Valenzuela J, Abd El Aziz M, Monsef I, Borchmann P, Estcourt LJ, Skoetz N, Goldkuhle M. Chimeric antigen receptor (CAR) T-cell therapy for people with relapsed or refractory diffuse large B-cell lymphoma. Cochrane Database Syst Rev. 2021 Sep 13;9(9):CD013365. doi: 10.1002/14651858.CD013365.pub2.
• Dasyam N, George P, Weinkove R. Chimeric antigen receptor T-cell therapies: Optimising the dose. Br J Clin Pharmacol. 2020 Sep;86(9):1678-1689. doi: 10.1111/bcp.14281. Epub 2020 Mar 24.

Drugs

Indications