Clinical Trials

Date: 2017-09-18

Type of information: update on patient enrollment

phase: 1-2

Announcement: completion of patient treatment

Company: Autolus (UK)

Product: AUTO2

Action mechanism:

cell therapy/immunotherapy product/gene therapy/CAR-T cell therapy. AUTO2 is a dual-targeting chimeric antigen receptor T-cell (CAR-T cell) product that targets both B-cell maturation antigen (BCMA) and transmembrane activator and calcium modulator and cyclophilin ligand interactor (TACI). BCMA is an antigen with low and variable expression on multiple myeloma cells. By targeting TACI in addition to BCMA on the same cancer cell, more patients may be eligible for CAR-T treatment with patients being at risk of cancer relapse due to loss of BCMA expression on their cancer. In addition, AUTO2 carries an RQR8 safety switch which allows the T-cells to be removed with a single high dose of rituximab.

Disease: multiple myeloma

Therapeutic area: Cancer - Oncology

Country: UK

Trial details:

The APRIL Study is a dose-escalation phase I/II study in which cohorts of patients receive ascending doses of AUTO2 to determine the maximum tolerated dose and establish a recommended dose. The second part of the study is an expansion phase where patients receive AUTO2 to further evaluate the safety, tolerability and clinical activity at this recommended dose. The APRIL study is named after the month in which the study was initiated, which is also the ligand the cell utilises to target the cancer. (EUDRA-CT 2016-003893-42)

Latest news:

• On September 18, 2017, Autolus announced completion of the first-dose cohort of its phase I/II study of its novel, dual-targeted chimeric antigen receptor T-cell (CAR-T cell) therapy, AUTO2, in patients with relapsed/refractory multiple myeloma. In the APRIL study, cohorts of patients will receive ascending doses of AUTO2 to determine the maximum tolerated dose and establish a recommended dose. The second part of the study is an expansion phase where patients receive AUTO2 to further evaluate the safety, tolerability and clinical activity at this recommended dose.