Clinical Trial

Disease: Relapsed or Refractory B-cell Acute Lymphoblastic Leukaemia, B-ALL, (2019-003462-40)

Disease info:

Leukaemia is cancer of the white blood cells which are responsible for fighting infection. In leukaemia, the bone marrow produces abnormal levels of white blood cells. B-cell acute lymphoblastic leukaemia (B-ALL) is an aggressive (fast-growing) type of leukaemia in which too many B-cell lymphoblasts (immature white blood cells) are found in the bone marrow and blood. It is the most common type of ALL. Also called B-cell acute lymphocytic leukaemia and precursor B-lymphoblastic leukaemia. 

Relapsed refers to when a patient has received active treatment, went off treatment and then the disease came back, whereas refractory refers to disease that is progressing despite active treatment.

ALL accounts for less than 1% of all cancers in the U.S., with around 6,540 new cases estimated in the U.S. in 2023. ALL is the most common type of cancer found in children, though it can affect adults too.
Official title:
Phase 1 , open label study of CRISPR-CAR genome edited T cells (TT52CAR19) in relapsed/refractory B Cell Acute Lymphoblastic Leukaemia

United Kingdom 

Study start:
Feb. 28, 2020
10 participants
Gene editing method:
Type of edit:
Gene insertion, gene knock-out
Caspase Recruitment Domain Family Member 19 (CAR19) T Cell Receptor Alpha and Beta Locus (TCRαβ)
Delivery method:
Lentiviral vector and electroporation - Ex-vivo
Safety updates:

No inforrmation 

IND Enabling Pre-clinical
Phase I Safety
Phase II Safety and Dosing
Phase III Safety and Efficacy

Status: Ongoing


TT52CAR19 therapy for B cell acute lymphoblastic leukaemia.

CAR19+ TCRαβ- T cells.

The study treatment consists of a single administration of TT52CAR19 product. No further administration is expected. Patients will be followed for 3 years after TT52CAR19 administration.

The primary objective of the study is to evaluate the safety of TT52CAR19 cell therapy in children with relapsed or refractory B acute lymphoblastic leukaemia (B-ALL).

The secondary objective is to determine if TT52CAR19 can mediate molecular remission by day 28 and thereby allow patients to proceed to allo-SCT.

Last updated: Dec. 28, 2023
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