AUTO-LT1 Long Term Follow Up Patients Treated with Autologous T Cells
Research type
Research Study
Full title
Long-term follow-up of patients previously treated with autologous T cells genetically modified with retroviral vectors.
IRAS ID
238141
Contact name
Claire Roddie
Contact email
Sponsor organisation
Autolus Limited
Eudract number
2016-004867-38
Duration of Study in the UK
25 years, 0 months, 0 days
Research summary
This is a long term follow up study for evaluation of patients that have previously received an investigational medicinal product (e.g. AUTO CAR T cell therapy) developed by Autolus Ltd. AUTO CAR T cells are a genetically modified product. The modified T cells given to patients are made by using a virus to deliver the genes into the patient’s own T cells. The patients for this study will come from the following Parent Studies that have already received GTAC, MHRA & HRA approval;
AUTO2-MM1 (APRIL) (REC ref: 16/LO/2008)
AUTO3-DB1 (ALEXANDER) (REC ref: 17/LO/0812)
AUTO3-PA1 (AMELIA)(Rec ref: 17/LO/0506)
AUTO4-TL1 (Rec ref: 17/LO/1730)Patients will roll-over from the parent study onto the long term follow up study.
Medicines that are made using gene therapy techniques need long-term follow-up to assess their safety in treated patients. Also, monitoring how the genes persist in the body and how well they work is important for the development of these advanced treatments.
The purpose of this study is to monitor all patients exposed to these modified T cells until death or for up to 15 years following their first infusion. Patients will be monitored every 3 months for the first year, every six months during years 2 to 5 and then annually for the following 10 years. At each visit patients will have assessments to check for delayed side-effects, to check how the modified cells are behaving in the body and to assess how well the modified cells work in the long-term.
No study drug will be given to patients involved in this trial. Patients will be assessed at each visit for survival, disease status, side-effects, any new cancer treatments and have blood tests taken to see how the modified T cells are behaving.
REC name
London - West London & GTAC Research Ethics Committee
REC reference
18/LO/0138
Date of REC Opinion
8 May 2018
REC opinion
Further Information Favourable Opinion