Date: 2017-09-18
Type of
information: Initiation of the trial
phase: 1-2
Announcement: initiation of the trial
Company: Autolus (UK)
Product: AUTO3
Action
mechanism:
- cell therapy/immunotherapy product/gene therapy/CAR-T cell therapy. AUTO3 is an autologous T-cell product, genetically modified to express two separate chimeric antigen receptors (CARs) which recognise CD19 and CD22 antigens expressed by cancer cells in B-cell leukaemia and lymphoma. It is believed to be the first dual-targeting CAR-T cell product to enter clinical development with both CARs delivered from a single retroviral vector during production.
- Clinical studies with anti-CD19 CAR T cells have demonstrated efficacy in treating acute lymphoblastic leukaemia and diffuse large B-cell lymphoma patients. However, a significant proportion of patients relapse due to CD19 downregulation. CD22 is another B-cell antigen that is expressed on B-cell lymphomas and leukaemias, and expression of CD22 is maintained on cancer cells that have lost CD19. By targeting both CD19 and CD22 simultaneously, AUTO3 may decrease relapse rates by reducing the risk of the cancer cells evading treatment by loss or downregulation of a single antigen.
Disease: diffuse large B-cell lymphoma (DLBCL)
Therapeutic
area: Cancer - Oncology
Country: UK
Trial
details:
- The ALEXANDER study is a phase I/II, open-label, multi-centre study to evaluate the safety and efficacy of AUTO3 administered by intravenous infusion in adult DLBCL patients. The phase I, dose escalation, is designed to identify the optimal dose in relapsed or refractory DLBCL patients. Phase II is an expansion phase where patients receive AUTO3 at the recommended dose to further evaluate the safety, tolerability and clinical activity at this recommended dose. In addition to evaluating the effects of AUTO3 alone, the study will also evaluate the effects of AUTO3 in combination with short-duration use of a checkpoint inhibitor. The study will initially enroll patients at several sites in the UK, with further sites in Europe and the US added later. (EUDRA-CT 2016-004682-11)
Latest
news:
- • On September 18th, 2017, Autolus announced initiation of both the AMELIA and ALEXANDER phase I/II studies of its novel, dual-targeting, AUTO3 Chimeric Antigen Receptor (CAR) T-cell therapy. The ALEXANDER Study is a dose-escalation phase I/II studies in adult diffuse large B-cell lymphoma in which cohorts of patients receive ascending doses of AUTO3 to determine the maximum tolerated dose and establish a recommended dose. The second part of the study is an expansion phase where patients receive AUTO3 to further evaluate the safety, tolerability and clinical activity at this recommended dose. In addition to the effects of AUTO3 alone, combination with short-duration use of a checkpoint inhibitor is also being evaluated in the ALEXANDER study.
Is
general: Yes
