Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06508931
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-02
Brief Title:
Safety and Efficacy Study of Zamtocabtagene Autoleucel MB-CART20191 in Pediatric Patients With Relapsed or Refractory B-Cell Neoplasms
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Single-arm Multi-center Open-label Phase II Study to Determine the Safety and Efficacy of MB-CART20191 in Pediatric Subjects With RelapsedRefractory rr Mature B-cell Neoplasms Who Have Relapsed After One or More Prior Therapies Including Subjects With Primary Refractory Disease
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DALY PED
Brief Summary:
This is a single-arm multi-center open-label Phase II study to determine the safety and efficacy of MB-CART20191 in pediatric and adolescent subjects aged between 6 months and 18 years 6 kg body weight BW with mature B-cell neoplasms and aggressive lymphomas that relapsed after or are refractory to one or more prior therapies including subjects with primary refractory disease
Detailed Description:
This is a single-arm multi-center open-label Phase II study designed to evaluate the efficacy of zamtocabtagene autoleucel MB-CART20191 therapy infusion in pediatric subjects with relapsedrefractory rr mature B-cell neoplasms The primary study endpoint will be best overall response BORR Furthermore the safety and toxicity of the study product will be assessed based on type frequency and severity of adverse events AEs serious adverse events SAEs and adverse events of special interest AESI
MB-CART20191 is designed to effectively target malignant B cells in patients suffering from haematological B-cell malignancies Zamtocabtagene autoleucel MB-CART20191 is a tandem CD20-CD19-directed non-cryopreserved CAR-T cell therapy Pediatric patients who are suitable for this study will be treated with MB-CART20191
Zamtocabtagene autoleucel MB-CART20191 administration consists of a single infusion with fresh formulation of 25 106 CAR-transduced autologous T cellskg bodyweight IMP is only to be administered after a lymphodepleting chemotherapy with fludarabine and cyclophosphamide For MB-CART20191 production pediatric patients will undergo a leukapheresis The enrollment period will last approximately 36 months and the duration of the study for each subject will be 85 weeks including screening period and a 78 weeks safety follow-up
MB-CART20191 is designed to effectively target malignant B cells in patients suffering from haematological B-cell malignancies Zamtocabtagene autoleucel MB-CART20191 is a tandem CD20-CD19-directed non-cryopreserved CAR-T cell therapy Pediatric patients who are suitable for this study will be treated with MB-CART20191
Zamtocabtagene autoleucel MB-CART20191 administration consists of a single infusion with fresh formulation of 25 106 CAR-transduced autologous T cellskg bodyweight IMP is only to be administered after a lymphodepleting chemotherapy with fludarabine and cyclophosphamide For MB-CART20191 production pediatric patients will undergo a leukapheresis The enrollment period will last approximately 36 months and the duration of the study for each subject will be 85 weeks including screening period and a 78 weeks safety follow-up
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None