MB-CART 19.1

P1/2, N=48, Recruiting, Miltenyi Biomedicine GmbH

Autologous CD19 CAR T cells MB-CART19.1 were produced with the Miltenyi prodigy platform. After leukapheresis on day -13, manufacturing commenced in house and lymphodepletion was started with fludarabine 25 mg/m2/d intravenously (i.v.) on days -5 to -3 and cyclophosphamide 1000 mg/m2/d i.v. on day -3...6/15 patients received tocilizumab... CD19 CAR T cells induce persistent, drug-free remission in three distinct autoantibody dependent AID with very good tolerability. Though hypothetical cure appears possible, longer follow up is needed. This unprecedented drug-free remission is remarkable as B cells functionally reconstitute.

P1/2, N=18, Active, not recruiting, Federal Research Institute of Pediatric Hematology, Oncology and Immunology | Trial completion date: Oct 2022 --> Oct 2025

P1/2, N=48, Recruiting, Miltenyi Biomedicine GmbH | Trial completion date: Jul 2022 --> Dec 2022 | Trial primary completion date: Jul 2021 --> Aug 2022

Subjects undergo lymphodepletion with fludarabine (25 mg/m 2 daily for 3 days) and cyclophosphamide (1000 mg/m 2 on day -3)...1 patient experienced grade III CRS and was treated with tocilizumab...Longer follow-up will establish whether treatment results in durable responses. The hybrid manufacturing model provides flexibility and a timely delivery of the fresh drug product to the patients

P1, N=9, Not yet recruiting, Metro North Hospital and Health Service

P1/2, N=18, Active, not recruiting, Federal Research Institute of Pediatric Hematology, Oncology and Immunology | Recruiting --> Active, not recruiting | Trial completion date: Mar 2023 --> Oct 2022 | Trial primary completion date: Mar 2023 --> Oct 2020

P1/2, N=48, Recruiting, Miltenyi Biomedicine GmbH | Trial completion date: Jul 2020 --> Jul 2022 | Trial primary completion date: Jul 2020 --> Jul 2021