Bicistronic CART cells targeting CD19 & CD22 show clinical activity in pediatric & young adult patients w/ B cell acute lymphoblastic leukemia, w/ relapses associated w/ limited CAR T cell persistence. ChildhoodCancerAwarenessMonth NMEDclinical
. Each cohort could treat up to six patients. Evaluation of a dose level required at least three patients treated at the planned dose level to have completed the 30 d DLT evaluation period to declare any dose cohort and schedule safe.
The study was approved by the UK Medicines and Healthcare Products Regulatory Agency , the London–West London and GTAC Research Ethics Committee , and the research and development department of each participating National Health Service trust. Autolus Therapeutics sponsored this clinical study. The trial was prospectively registered and entered in the EUDRA CT database on 3 March 2017 . The study was posted at ClinicalTrials.gov on 21 September 2017 .
An independent data monitoring committee , consisting of two independent physicians and one statistician, was established by the Sponsor to review serious safety events. The IDMC were scheduled to meet when any safety stopping criteria were met.Eligible patients were male or female children and young adults with relapsed or refractory B-lineage ALL.The inclusion criteria are as follows.
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