Disease: Relapsed or Refractory B-cell Acute Lymphoblastic Leukaemia, B-ALL, (NCT04154709)
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.
Frequency:
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:
CTA101 UCAR-T Cell Injection for Treatment of Relapsed or Refractory CD19+ B-cell Acute Lymphoblastic Leukemia
This study aims to evaluate the safety and feasibility of CTA101 in treating patients with relapsed or refractory CD19+ B-cell acute lymphoblastic leukemia. CTA101 is a CRISPR-Cas9 engineered, off-the-shelf, CD19/CD22 dual-targeted CAR T cell product. Study participants will receive one infusion of Universal CD19-directed CAR-T cells in escalating doses.