Ignite Creation Date:
2024-05-06 @ 3:01 PM
Last Modification Date:
2024-10-26 @ 1:41 PM
Study NCT ID:
NCT04499573
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-02-22
First Post:
2020-07-31
Brief Title:
Bispecific CD19CD22 CAR-T for Treatment of Children and Young Adults With rr B-ALL
Sponsor:
Federal Research Institute of Pediatric Hematology Oncology and Immunology
Organization:
Federal Research Institute of Pediatric Hematology Oncology and Immunology
Study Overview
Official Title:
Safety and Efficiency of Anti-CD19CD22 Tandem Fully Human Chimeric Antigen Receptor CAR-Transduced T-cell Therapy for Pediatric and Young Adult Patients With RelapsedRefractory B-cell Acute Lymphoblastic Leukemia a Single Centre Non-randomised Open Label Phase I-II Clinical Trial of Automatically Produced Cell Therapy Product MB-CAR-T19-22 Using CliniMACS Prodigy
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the safety and efficiency of autologous CD19CD22 CAR-T lymphocytes in a cohort of pediatric and young adult patients with relapsed refractory B-lineage acute lymphoblastic leukemia
Detailed Description:
The main objectives of the study are
To investigate the incidence of adverse events of grade 3-5 within after CD19CD22 CAR lymphocyte infusion by day 28
To evaluate the incidence of complete remission and MRD-negative CR by day 28
To evaluate the long-term effectiveness of CD19CD22 CAR-T therapy cumulative incidence of relapse event-free survival overall survival at 1 2 and 5 years after infusion
To evaluate the persistence of CD19CD22 CAR-T cells and duration of B-cell aplasia 1 B-cells in the blood and hypogammaglobulinemia In order to prevent the development of CRS all patients will receive an infusion of tocilizumab at 8 mgkg body weight on day 0 before CAR-T cells infusion
Step-down and step-up dosing will be used to adapt the trial to the scenario of excess toxicity andor suboptimal effect Reevaluation of dosing will be done for each cohort separately after the enrollment 5th study subject reaches day 28 or earlier if the threshold for excess toxicity or suboptimal effect is achieved
Based on interim analysis in March 2021 after the enrollment 5th study subject reaches day 28 study population will be divided into three cohorts
1 CD19-positive both CD19 and CD22 expressed on over 50 of leukemia cells low and high disease burden
2 CD19-negative CD22 expressed on over 50 of leukemia cells low and high disease burden
3 Allogeneic HSCT allogeneic CAR-T cohort
To investigate the incidence of adverse events of grade 3-5 within after CD19CD22 CAR lymphocyte infusion by day 28
To evaluate the incidence of complete remission and MRD-negative CR by day 28
To evaluate the long-term effectiveness of CD19CD22 CAR-T therapy cumulative incidence of relapse event-free survival overall survival at 1 2 and 5 years after infusion
To evaluate the persistence of CD19CD22 CAR-T cells and duration of B-cell aplasia 1 B-cells in the blood and hypogammaglobulinemia In order to prevent the development of CRS all patients will receive an infusion of tocilizumab at 8 mgkg body weight on day 0 before CAR-T cells infusion
Step-down and step-up dosing will be used to adapt the trial to the scenario of excess toxicity andor suboptimal effect Reevaluation of dosing will be done for each cohort separately after the enrollment 5th study subject reaches day 28 or earlier if the threshold for excess toxicity or suboptimal effect is achieved
Based on interim analysis in March 2021 after the enrollment 5th study subject reaches day 28 study population will be divided into three cohorts
1 CD19-positive both CD19 and CD22 expressed on over 50 of leukemia cells low and high disease burden
2 CD19-negative CD22 expressed on over 50 of leukemia cells low and high disease burden
3 Allogeneic HSCT allogeneic CAR-T cohort
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None