AUTO6 / Autolus, University College London - LARVOL DELTA

A Cancer Research UK phase I trial of anti-GD2 chimeric antigen receptor (CAR) transduced T-cells (1RG-CART) in patients with relapsed or refractory neuroblastoma (AACR 2018) - P1; "Both lymphodepletion and CART dose were escalated as follows: dose level (DL) 1 without lymphodepletion, DL2 with 1.2 g/m2 cyclophosphamide and DL3 and beyond 1.2 g/m2 cyclophosphamide and 125 mg/m2 fludarabine followed by administration of a single intravenous dose of 1x107/m2 (DL1-3) or 1x108/m2 (DL4) 1RG-CART. These preliminary results are the first to demonstrate on-target activity in bone and bone marrow of GD2-CART in this childhood solid tumour. Further 1RG-CART dose escalation is warranted, and under way."

Clinical • P1 data • Neuroendocrine Tumor

A Cancer Research UK Trial of Anti-GD2 T-cells (1RG-CART) (clinicaltrials.gov) - P1; N=17; Completed; Sponsor: Cancer Research UK; Recruiting ➔ Completed; N=27 ➔ 17; Trial completion date: Feb 2023 ➔ Dec 2020; Trial primary completion date: Feb 2023 ➔ Dec 2020

Clinical • Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Neuroblastoma • Oncology • Solid Tumor

Autolus Therapeutics announces publication of new AUTO6 Phase 1 data in childhood neuroblastoma in Science Translational Medicine (GlobeNewswire) - P1, N=27; NCT02761915; "These new results highlight that AUTO6 can induce rapid regression of bulky disease in a solid tumor setting without inducing on-target off-tumor toxicity, despite dose dependent CAR T expansion. CAR T cell expansion was observed in all six patients treated at the higher cell dose cohorts in this Phase 1 study. Three of these six patients demonstrated evidence of transient CAR T cell activity, including cytokine release syndrome, and regression of soft tissue and bone marrow disease activity...Autolus plans to test AUTO6NG in a Phase 1 study in 2021."

New P1 trial • P1 data • Neuroblastoma • Oncology