The 62nd ASH annual conference, originally scheduled to be held in San Diego, California, took place during December 5 – 8 as an ‘all-virtual event’ due to the COVID-19 pandemic. ALLCAR19, a phase I trial investigating novel CD19 CAR T-cells as treatment for patients with high risk/relapsed acute lymphoblastic leukaemia (r/rALL), was presented at the meeting by Dr Claire Roddie (Consultant Haematologist and Principal Investigator at University College London Hospital).
Until November 2020, 20 r/r ALL patients were treated with these CAR T-cells. The safety profile was good despite the patients’ high disease burden and multiples lines of previous treatment. No patients experienced severe (≥ grade 3) cytokine release syndrome (CRS), the most common side effect for similar CAR T products. Only 3 out of the 20 patients experienced grade 3 neurotoxicity (also called ICANS), which resolved rapidly with steroids. Importantly, the CAR T cells expanded well and persisted for long time in the patients. The CAR T-cells showed promising efficacy results with 84% of the patients achieving minimal residue disease (MRD) negative complete response at 1 month after the CAR T infusion. The response was durable with 69% of the patients still disease-free at 6 months and 52% maintaining disease response at 12 months after the CAR T infusion. Ongoing complete remissions were observed beyond 24 months, supporting the use of these CAR T-cells as a stand-alone therapy.
The study was recently expanded to small cohorts of patients with diffuse large B-cell lymphoma, chronic lymphocytic leukaemia/ small lymphocytic lymphoma and indolent B-Non-Hodgkin Lymphoma (B-NHL). Four patients (all from the indolent B-NHL cohort) were treated at the time of the presentation. None of the patients experienced grade ≥3 CRS or any neurotoxicity. All 4 patients achieved complete metabolic response at 1 month after the CAR T-cells infusion.
Speaking after the event, Dr Claire Roddie noted: 'The high level of sustained complete responses observed with these CAR T-cells in adult ALL, achieved without subsequent stem cell transplant, point to a potentially transformational treatment for adult ALL.
'Despite high disease burden and despite this being a heavily pre-treated patient population on study, the CAR T-cells remain well tolerated. It’s encouraging to also observe promising early activity and safety in indolent NHL.'
For further information on the presentation, please see the
ASH website.
For more information on the ALLCAR19 trial, please see the
CTC trial pages.