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The incidence of B-cell acute lymphoblastic leukemia (ALL) has a bimodal distribution.
The first peak occurs in childhood and the second peak occurs around 50 years of age
.
Although the prognosis of children has improved in the past few decades, the prognosis of the elderly remains poor
.
Despite the high response rate to induction chemotherapy, only 30%-40% of adult ALL patients can achieve long-term remission
.
The prognosis of patients with primary refractory and chemotherapy refractory B-cell ALL is extremely poor
.
The chimeric antigen receptor (CAR) targeting CD19 B lymphocyte molecules provides an option for the treatment of B cell malignancies
.
The team of Professor Wang Jianxiang from the Hospital of Hematology, Chinese Academy of Medical Sciences explored the safety and efficacy of CNCT19 (a self-targeting CD19 gene-modified T cell immunotherapy) in the treatment of relapsed and refractory (R/R) ALL adults and children.
The study Selected for the poster presentation of this year's ASH annual meeting, the editor organizes its main content as follows for the reference of readers
.
Research method An open-label phase 1/2 clinical trial evaluated the safety and efficacy of CNCT19 in the treatment of adults and children with R/R ALL who have failed ≥2 lines of treatment
.
According to the standards of the local hospital, white-pack cell isolation was performed to obtain T cells
.
CNCT19 was infused 2-14 days after lymphocyte depletion chemotherapy
.
All patients were hospitalized for 2 weeks
.
The main goal of the study is to determine safety and clinical outcomes, including overall response rate (ORR), progression-free survival (PFS) and overall survival (OS) within 3 months
.
Results of the study as of October 2020, 63 patients (adults [>18 years]: n=32; children [<18 years]: n=31) have received CNCT19 treatment, and all subjects have been followed up for at least 1 Years
.
Adverse events (AE) of any grade occurred in 54 patients (54/63; 85.
7%)
.
Respectively, 12 patients (12/63; 19%) and 13 patients (13/63; 20%) had ≥3 grade cytokine release syndrome (CRS) and neurological events (NE)
.
ORR was 93.
6% (59/63) (defined as complete remission [CR] and complete remission with incomplete hematological recovery [CRi])
.
Among 59 responders, 56 patients (56/69; 94.
9%) had minimal residual disease (MRD) negative, and 23 patients (38.
9%) received allogeneic hematopoietic stem cell transplantation
.
The recurrence-free survival (RFS) rate and OS rate of the adult group and the child group are detailed in the table below
.
Research conclusions CNCT19 treatment of children and adults with R/R ALL showed improvement in ORR, PFS and OS
.
A key clinical trial is underway in China to evaluate ORR, PFS, and OS, and a clinical plan to reduce the severity of treatment-related adverse events (CRS/NE) has been developed
.
Reference source: Ying Wang, et al.
2021 ASH.
Abstract #2811.
Stamp "read the original text" and we will make progress together
The first peak occurs in childhood and the second peak occurs around 50 years of age
.
Although the prognosis of children has improved in the past few decades, the prognosis of the elderly remains poor
.
Despite the high response rate to induction chemotherapy, only 30%-40% of adult ALL patients can achieve long-term remission
.
The prognosis of patients with primary refractory and chemotherapy refractory B-cell ALL is extremely poor
.
The chimeric antigen receptor (CAR) targeting CD19 B lymphocyte molecules provides an option for the treatment of B cell malignancies
.
The team of Professor Wang Jianxiang from the Hospital of Hematology, Chinese Academy of Medical Sciences explored the safety and efficacy of CNCT19 (a self-targeting CD19 gene-modified T cell immunotherapy) in the treatment of relapsed and refractory (R/R) ALL adults and children.
The study Selected for the poster presentation of this year's ASH annual meeting, the editor organizes its main content as follows for the reference of readers
.
Research method An open-label phase 1/2 clinical trial evaluated the safety and efficacy of CNCT19 in the treatment of adults and children with R/R ALL who have failed ≥2 lines of treatment
.
According to the standards of the local hospital, white-pack cell isolation was performed to obtain T cells
.
CNCT19 was infused 2-14 days after lymphocyte depletion chemotherapy
.
All patients were hospitalized for 2 weeks
.
The main goal of the study is to determine safety and clinical outcomes, including overall response rate (ORR), progression-free survival (PFS) and overall survival (OS) within 3 months
.
Results of the study as of October 2020, 63 patients (adults [>18 years]: n=32; children [<18 years]: n=31) have received CNCT19 treatment, and all subjects have been followed up for at least 1 Years
.
Adverse events (AE) of any grade occurred in 54 patients (54/63; 85.
7%)
.
Respectively, 12 patients (12/63; 19%) and 13 patients (13/63; 20%) had ≥3 grade cytokine release syndrome (CRS) and neurological events (NE)
.
ORR was 93.
6% (59/63) (defined as complete remission [CR] and complete remission with incomplete hematological recovery [CRi])
.
Among 59 responders, 56 patients (56/69; 94.
9%) had minimal residual disease (MRD) negative, and 23 patients (38.
9%) received allogeneic hematopoietic stem cell transplantation
.
The recurrence-free survival (RFS) rate and OS rate of the adult group and the child group are detailed in the table below
.
Research conclusions CNCT19 treatment of children and adults with R/R ALL showed improvement in ORR, PFS and OS
.
A key clinical trial is underway in China to evaluate ORR, PFS, and OS, and a clinical plan to reduce the severity of treatment-related adverse events (CRS/NE) has been developed
.
Reference source: Ying Wang, et al.
2021 ASH.
Abstract #2811.
Stamp "read the original text" and we will make progress together
