B-cell Acute Lymphoblastic Leukemia is an aggressive (fast-growing) type of leukemia (blood cancer) 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 acute lymphoblastic leukemia (ALL). Also called B-cell acute lymphocytic leukemia and precursor B-lymphoblastic leukemia.
Disease: B- cell Acute Lymphoblastic Leukaemia, ALL, (2019-003462-40)
Disease info:
Frequency:
The American Cancer Society’s estimates for acute lymphocytic leukemia (ALL) in the United States for 2020 are: About 6,150 new cases of ALL (3,470 in males and 2,680 in females) About 1,520 deaths from ALL (860 in males and 660 in females)
Official title:
Phase 1 , open label study of CRISPR-CAR genome edited T cells (TT52CAR19) in relapsed /refractory B Cell Acute Lymphoblastic Leukaemia
Who:
No information
Partners:
No information
Locations:
United Kingdom
Study start:
Mar. 30, 2020
Enrollment:
10 participants
Gene editing method:
CRISPR-Cas
Type of edit:
Gene insertion, gene knock-out
Gene:
Caspase Recruitment Domain Family Member 19 (CAR19)
T Cell Receptor Alpha and Beta Locus (TCRαβ)
Delivery method:
- 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
Description
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: Apr. 10, 2022Source: EU Clinical Trials Register
clinicaltrialsregister.eu
clinicaltrialsregister.eu
