AUTO1 in relapsed or refractory B-ALL and B-NHL
Research type
Research Study
Full title
A Single-Arm, Open-Label, Multi-Centre, Phase Ib Study Evaluating the Safety and Preliminary Efficacy of AUTO1 in Pediatric Patients with CD19-Positive Relapsed/ Refractory (r/r) B-cell Acute Lymphoblastic Leukemia (BALL) and Aggressive Mature B-cell Non-Hodgkin Lymphoma (BNHL).
IRAS ID
1007600
Contact name
Kajal Sonara
Contact email
Sponsor organisation
Autolus Ltd.
Research summary
B-Cell Acute lymphoblastic leukaemia (ALL) is a blood cancer that is common in both children and teens. B-Cell Non-Hodgkin’s Lymphoma (NHL) is a cancer of the lymphatic system. ALL and NHL are serious and life-threatening diseases and will progress rapidly if left untreated. There are several treatments available, including chemotherapy, immunotherapy and stem cell or bone marrow transplant. Despite this, patients relapse and have a low chance of cure with conventional treatments and chances of long-term survival remain low.
Since most patients have had the maximal tolerable dose of chemotherapy, it is highly desirable to develop safe and effective new therapies such as a CAR T cell therapy that avoid the mortality, and morbidity associated with current therapy.
T-cells are white blood cells part of our immune system. Their function is to move around our body and destroy cells infected with a virus. T-cells are not always able to detect cancer cells. This study tests a way of "re-programming" T-cells so they recognise ALL/NHL cells.
This study includes participants less than 18 years old and will have ALL or NHL which has come back and no longer responds to standard treatment.
Cells with be collected through a machine which separates out white blood cells and returns the rest of the blood to the participant. The participants own T-cells are taken to a specialised laboratory. Here, a new gene is inserted into the T-cells. This gene instructs the T-cells to make a new protein called a "chimeric antigen receptor" (CAR). This CAR (known as AUTO1) allows the T-cells to recognise and kill leukaemia (ALL) and lymphoma (NHL) cells.
The AUTO1 CAR T-cells are given back to the participant via an intravenous drip. Participants will be followed up for 24 months after AUTO1 to check how safe and effective AUTO1 is.REC name
London - West London & GTAC Research Ethics Committee
REC reference
23/LO/0432
Date of REC Opinion
7 Sep 2023
REC opinion
Further Information Favourable Opinion