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160 ALLCAR19: Updated Data Using AUTO1, a Novel Fast-Off Rate CD19 CAR in Relapsed/Refractory B-Cell Acute Lymphoblastic Leukaemia and Other B-Cell MalignanciesClinically Relevant Abstract

Program: Oral and Poster Abstracts
Type: Oral
Session: 614. Acute Lymphoblastic Leukemia: Therapy, excluding Transplantation: Chimeric Antigen Receptor T Cell Therapy
Hematology Disease Topics & Pathways:
Biological, Adult, CAR-Ts, Therapies, immunotherapy, Study Population
Saturday, December 5, 2020: 12:15 PM

Claire Roddie, PhD, MD1*, Maeve A O'Reilly, MBBCHBAO2, Maria A V Marzolini3*, Leigh Wood, BA4*, Juliana Dias5*, Amaia Cadinanos Garai, BSc MSc5*, Leticia Bosshard3*, Mahnaz Abbasian3*, Mark W. Lowdell, BSc, MSc, PhD, FRCPath6*, Graham Wheeler7*, Joanna Olejnik8*, Bilyana Popova, MSc9*, Laura Clifton-Hadley, PhD, BSc10*, Yashma Pathak11*, Victoria Spanswick3*, Helen Lowe11*, John A. Hartley, PhD3*, Farhatullah Syed12*, Waseem Qasim, MBBS, PhD13*, Farzin Farzaneh, PhD14*, David C. Linch12*, Martin Pule, MD PhD3* and Karl S Peggs, MD, PhD15*

1Department of Haematology, Clinical Lead, CAR-T, University College London Hospitals Senior Lecturer in Haematology, University College London NHS Foundation Trust, London, United Kingdom
2Department of Haematology, University College London Hospitals NHS Foundation Trust, London, United Kingdom
3UCL Cancer Institute, London, United Kingdom
4University College Hospital London, london, United Kingdom
5Cancer Institute, University College London, London, United Kingdom
6Cellular Therapeutics, University College London, London, United Kingdom
7Cancer Research UK & UCL Cancer Trials Centre, UCL, London, United Kingdom
8UCL Cancer Trials Centre, London, United Kingdom
9CRUK UCL Cancer Trials Centre, UCL, London, United Kingdom
10Cancer Research UK and UCL Cancer Trials Centre, London, United Kingdom
11UCL Cancer Institute, University College London, London, United Kingdom
12University College London, London, United Kingdom
13Institute of Child Health, UCL, London, ENG, United Kingdom
14King's College London, London, United Kingdom
15University College London Cancer Institute, UCL Cancer Institute, London, United Kingdom


Prognosis for adult B-cell Acute Lymphoblastic Leukaemia (B-ALL) is poor and there is currently no licensed CD19 Chimeric Antigen Receptor (CAR) therapeutic. We developed a novel CD19 CAR (CAT-41BBz CAR) with a fast off-rate, designed to result in more physiological T-cell activation, reduce toxicity and improve engraftment. We describe updated data from the Phase I ALLCAR19 (NCT02935257) study of AUTO1 in relapsed/refractory adult B-ALL.


Manufacturing: AUTO1 utilises non-mobilised autologous leukapheresate. The first 6 products were generated using a standard dynabead/WAVE bioreactor process and subsequent products using a semi-automated closed process.

Study design: Patients aged >16y underwent lymphodepletion with fludarabine (30mg/m2 x3) and cyclophosphamide (60mg/kg x1) followed by split dose CAR T-cell infusion (Day 0: if ≥20% Bone Marrow (BM) blasts, infuse 10 x 106 CAR T-cells; if <20% BM blasts, 100 x 106 CAR T-cells. At Day+9: if no grade 3-5 Cytokine Release Syndrome (CRS)/immune effector cell associated neurotoxicity syndrome (ICANS), infuse Dose 2, to a total dose of 410 x106 CAR T-cells). Study endpoints include feasibility of manufacture, grade 3-5 toxicity and remission rates at 1 and 3 months.


As of 13 May 2020, 24 patients have been leukapheresed, 23 products manufactured and 19 patients received at least 1 dose of AUTO1. The median age was 43y (range 18-62), 26% had prior blinatumomab, 47% had prior inotuzumab ozogamicin and 63% had prior hematopoietic stem cell transplantation (HSCT). At the time of pre-conditioning, 42% had ≥50% BM blasts.

No patients experienced ≥Grade 3 CRS (Lee criteria), 3/19 (16%) experienced Grade 3 ICANS that swiftly resolved with steroids. Of 19 infused patients, 16/19 (84%) achieved Minimal Residual Disease (MRD) negative complete response (CR). Currently 6 patients have died, none related to AUTO1. 11/19 (58%) patients remain on study and continue in MRD negative remission at a median follow up of 12.2 months (range 0.6-24.4m). To date, only 2 patients underwent HSCT whilst in remission. For all treated patients, the event-free survival (EFS) at 6 months was 62% and 76% for those whose products were manufactured using the closed process. Patients exhibited robust CAR expansion (mean peak CAR T levels 716,769 copies/µg DNA).


AUTO1 has a tolerable safety profile in adult patients with r/r B-ALL despite high disease burden. Early data shows high remission rates with 84% achieving MRD negative CR. This preliminary data supports the further development of AUTO1 as a standalone treatment in patients with r/r B-ALL. Data from additional patients and longer follow up will be presented. Furthermore, data from extension cohorts of patients with low- and high- grade B-cell Non-Hodgkin’s lymphoma and chronic lymphocytic leukaemia will be presented.

Disclosures: Roddie: Celgene: Honoraria; Gilead: Honoraria; Novartis: Honoraria. O'Reilly: Gilead: Honoraria; Novartis: Honoraria, Other: Travel support. Hartley: ADC Therapeutics: Consultancy, Current equity holder in publicly-traded company, Research Funding. Linch: Autolus: Consultancy. Pule: UCLB: Patents & Royalties; Mana Therapeutics: Other: entitled to share of revenue from patents filed by UCL; Autolus: Current Employment, Other: owns stock in and receives royalties, Patents & Royalties. Peggs: Autolus: Consultancy.

*signifies non-member of ASH